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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00073528




Registration number
NCT00073528
Ethics application status
Date submitted
24/11/2003
Date registered
26/11/2003
Date last updated
24/02/2021

Titles & IDs
Public title
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
CLAP016A2308
Secondary ID [2] 0 0
EGF30008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lapatinib
Treatment: Drugs - Letrozole
Treatment: Drugs - Placebo

Placebo comparator: Placebo + Letrozole 2.5 mg - Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)

Experimental: Lapatinib 1500 mg + Letrozole 2.5 mg - Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)


Treatment: Drugs: Lapatinib
1500 mg orally once a day

Treatment: Drugs: Letrozole
2.5 mg orally once a day

Treatment: Drugs: Placebo
Placebo (which matched with lapatinib tablet)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator
Assessment method [1] 0 0
PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
Timepoint [1] 0 0
From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months
Primary outcome [2] 0 0
Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator
Assessment method [2] 0 0
PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [1] 0 0
Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator
Assessment method [1] 0 0
PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
Timepoint [1] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [2] 0 0
PFS in Participants in the ITT Population as Assessed by the Investigator
Assessment method [2] 0 0
PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [3] 0 0
Overall Survival in the HER2-Positive Population
Assessment method [3] 0 0
Overall survival was defined as the time from randomization until death due to any cause.
Timepoint [3] 0 0
From date of randomization until date of death due to any cause, assessed up to 46 months
Secondary outcome [4] 0 0
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Assessment method [4] 0 0
OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 \* (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.
Timepoint [4] 0 0
Up to 46 months
Secondary outcome [5] 0 0
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Assessment method [5] 0 0
Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval \[DI\] =\>6 months or DI \<6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.
Timepoint [5] 0 0
Up to 46 months
Secondary outcome [6] 0 0
Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator
Assessment method [6] 0 0
CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.
Timepoint [6] 0 0
Up to 46 months
Secondary outcome [7] 0 0
Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.
Assessment method [7] 0 0
CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.
Timepoint [7] 0 0
Up to 46 months
Secondary outcome [8] 0 0
Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.
Assessment method [8] 0 0
CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.
Timepoint [8] 0 0
Up to 46 months
Secondary outcome [9] 0 0
Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator
Assessment method [9] 0 0
Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.
Timepoint [9] 0 0
Up to 46 months
Secondary outcome [10] 0 0
Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator
Assessment method [10] 0 0
Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.
Timepoint [10] 0 0
Up to 46 months
Secondary outcome [11] 0 0
Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population
Assessment method [11] 0 0
The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.
Timepoint [11] 0 0
Up to 46 months
Secondary outcome [12] 0 0
Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator
Assessment method [12] 0 0
TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.
Timepoint [12] 0 0
Up to 46 months
Secondary outcome [13] 0 0
Overall Survival in the ITT Population
Assessment method [13] 0 0
Overall survival was defined as the time from randomization until death due to any cause.
Timepoint [13] 0 0
From date of randomization until date of death due to any cause, assessed up to 46 months
Secondary outcome [14] 0 0
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator
Assessment method [14] 0 0
OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 \* (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.
Timepoint [14] 0 0
Up to 46 months
Secondary outcome [15] 0 0
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator
Assessment method [15] 0 0
Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval \[DI\] =\>6 months or DI \<6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.
Timepoint [15] 0 0
Up to 46 months
Secondary outcome [16] 0 0
Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator
Assessment method [16] 0 0
CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.
Timepoint [16] 0 0
Up to 46 months
Secondary outcome [17] 0 0
Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator
Assessment method [17] 0 0
Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.
Timepoint [17] 0 0
Up to 46 months
Secondary outcome [18] 0 0
Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator
Assessment method [18] 0 0
Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.
Timepoint [18] 0 0
Up to 46 months
Secondary outcome [19] 0 0
Number of Participants With Evidence of Brain Metastases From the ITT Population
Assessment method [19] 0 0
The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.
Timepoint [19] 0 0
Up to 46 months
Secondary outcome [20] 0 0
TTP for Participants From the ITT Population as Assessed by the Investigator
Assessment method [20] 0 0
TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.
Timepoint [20] 0 0
Up to 46 months
Secondary outcome [21] 0 0
Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits
Assessment method [21] 0 0
Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 \[not at all\] to 4 \[very much\]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.
Timepoint [21] 0 0
Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit
Secondary outcome [22] 0 0
Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data
Assessment method [22] 0 0
Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.
Timepoint [22] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [23] 0 0
Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data
Assessment method [23] 0 0
FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.
Timepoint [23] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [24] 0 0
Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data
Assessment method [24] 0 0
The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.
Timepoint [24] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [25] 0 0
Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores
Assessment method [25] 0 0
A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID =\> 8 for the FACT-B score, and an MID =\>6 for the FACT-G and TOI scores.
Timepoint [25] 0 0
Up to 46 months
Secondary outcome [26] 0 0
Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status
Assessment method [26] 0 0
Clinical benefit: participants with CR, PR, or SD for =\>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.
Timepoint [26] 0 0
Up to 46 months
Secondary outcome [27] 0 0
Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity
Assessment method [27] 0 0
IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =\>6-month period.
Timepoint [27] 0 0
Up to 46 months
Secondary outcome [28] 0 0
Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower
Assessment method [28] 0 0
The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.
Timepoint [28] 0 0
Up to 46 months
Secondary outcome [29] 0 0
Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive
Assessment method [29] 0 0
Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =\<15 ng/mL but later had at least two consecutive serum HER2 ECD values \>15 ng/mL experienced seroconversion.
Timepoint [29] 0 0
Up to 46 months
Secondary outcome [30] 0 0
Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive
Assessment method [30] 0 0
Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (\>15 ng/mL) on two consecutive occasions.
Timepoint [30] 0 0
Up to 46 months
Secondary outcome [31] 0 0
Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline
Assessment method [31] 0 0
EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).
Timepoint [31] 0 0
Baseline

Eligibility
Key inclusion criteria
Key inclusion criteria

1. Signed informed consent;
2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;

* Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
* If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.
3. Tumors that were ER+ and/or PgR+;
4. Post-menopausal female subjects = 18 years of age.
5. ECOG Performance Status of 0 or 1;
6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.
8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.

Key exclusion criteria:

1. Pre-menopausal, pregnant, or lactating;
2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;
4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)
6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/03/2018
Sample size
Target
Accrual to date
Final
1286
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Douglas
Recruitment hospital [3] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [4] 0 0
Novartis Investigative Site - Redcliffe
Recruitment hospital [5] 0 0
Novartis Investigative Site - Adelaide
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Vermont
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
West Virginia
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autonoma de Buenos Aires
Country [35] 0 0
Brazil
State/province [35] 0 0
Bahía
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio de Janeiro
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Plovdiv
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Canada
State/province [39] 0 0
Manitoba
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Chile
State/province [42] 0 0
Región Metro De Santiago
Country [43] 0 0
Colombia
State/province [43] 0 0
Bogota
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Croatia
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Osijek
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Croatia
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Pula
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Croatia
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Split
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Czechia
State/province [47] 0 0
Brno
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Czechia
State/province [48] 0 0
Ceske Budejovice
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Czechia
State/province [49] 0 0
Praha 8
Country [50] 0 0
Denmark
State/province [50] 0 0
Aalborg
Country [51] 0 0
Denmark
State/province [51] 0 0
Hillerod
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Denmark
State/province [52] 0 0
Koebenhavn Oe
Country [53] 0 0
Denmark
State/province [53] 0 0
Naestved
Country [54] 0 0
Denmark
State/province [54] 0 0
Odense C
Country [55] 0 0
Denmark
State/province [55] 0 0
Roskilde
Country [56] 0 0
Denmark
State/province [56] 0 0
Vejle
Country [57] 0 0
France
State/province [57] 0 0
Angers Cedex 01
Country [58] 0 0
France
State/province [58] 0 0
Besancon
Country [59] 0 0
France
State/province [59] 0 0
Grenoble Cedex 9
Country [60] 0 0
France
State/province [60] 0 0
Lille Cedex
Country [61] 0 0
France
State/province [61] 0 0
Montpellier
Country [62] 0 0
France
State/province [62] 0 0
Paris Cedex 5
Country [63] 0 0
France
State/province [63] 0 0
Pierre Benite Cedex
Country [64] 0 0
France
State/province [64] 0 0
Toulouse Cedex9
Country [65] 0 0
France
State/province [65] 0 0
Villejuif Cedex
Country [66] 0 0
Germany
State/province [66] 0 0
Baden-Wuerttemberg
Country [67] 0 0
Germany
State/province [67] 0 0
Bayern
Country [68] 0 0
Germany
State/province [68] 0 0
Hessen
Country [69] 0 0
Germany
State/province [69] 0 0
Niedersachsen
Country [70] 0 0
Germany
State/province [70] 0 0
Nordrhein-Westfalen
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Germany
State/province [71] 0 0
Rheinland-Pfalz
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Germany
State/province [72] 0 0
Sachsen
Country [73] 0 0
Germany
State/province [73] 0 0
Schleswig-Holstein
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Germany
State/province [74] 0 0
Thueringen
Country [75] 0 0
Germany
State/province [75] 0 0
Berlin
Country [76] 0 0
Germany
State/province [76] 0 0
Hamburg
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Hungary
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Budapest
Country [78] 0 0
Hungary
State/province [78] 0 0
Kecskemet
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Hungary
State/province [79] 0 0
Kistarcsa
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Hungary
State/province [80] 0 0
Szeged
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Hungary
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Tatabanya
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Cork
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Ireland
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Dooradoyle
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Ireland
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Ireland
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Galway
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Ireland
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Tallaght, Dublin
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Ireland
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Wilton, Cork
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Italy
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Italy
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Lazio
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Italy
State/province [90] 0 0
Liguria
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Italy
State/province [91] 0 0
Lombardia
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seodaemun-gu, Seoul
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Korea, Republic of
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Guerrero
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Mexico
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Mexico
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Mexico
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Netherlands
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Netherlands
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Den Haag
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Netherlands
State/province [102] 0 0
Doetinchem
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Netherlands
State/province [103] 0 0
Eindhoven
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Netherlands
State/province [104] 0 0
Heerlen
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Netherlands
State/province [105] 0 0
Leidschendam
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Netherlands
State/province [106] 0 0
Maastricht
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Netherlands
State/province [107] 0 0
Nieuwegein
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Netherlands
State/province [108] 0 0
Sittard-geleen
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Netherlands
State/province [109] 0 0
Utrecht
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New Zealand
State/province [110] 0 0
Christchurch
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Pakistan
State/province [111] 0 0
Lahore
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Pakistan
State/province [112] 0 0
Rawalpindi
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Peru
State/province [113] 0 0
Callao
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Peru
State/province [114] 0 0
Lima
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Poland
State/province [115] 0 0
Bydogoszcz
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Poland
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Russian Federation
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Moscow
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Russian Federation
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Capital Park
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Parktown
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South Africa
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Port Elizabeth
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Spain
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Alcala De Henares (Madrid)
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Spain
State/province [127] 0 0
Badalona
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Spain
State/province [128] 0 0
Barcelona
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Spain
State/province [129] 0 0
Elche
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Spain
State/province [130] 0 0
Girona
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Spain
State/province [131] 0 0
Leganes, Madrid
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Spain
State/province [132] 0 0
Madrid
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Spain
State/province [133] 0 0
Malaga
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Spain
State/province [134] 0 0
Mostoles
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Spain
State/province [135] 0 0
Oviedo
Country [136] 0 0
Spain
State/province [136] 0 0
Palma de Mallorca
Country [137] 0 0
Spain
State/province [137] 0 0
San Sebastian
Country [138] 0 0
Spain
State/province [138] 0 0
Valencia
Country [139] 0 0
Spain
State/province [139] 0 0
Vigo ( Pontevedra)
Country [140] 0 0
Spain
State/province [140] 0 0
Zaragoza
Country [141] 0 0
Tunisia
State/province [141] 0 0
Sfax
Country [142] 0 0
Tunisia
State/province [142] 0 0
Sousse
Country [143] 0 0
Tunisia
State/province [143] 0 0
Tunis
Country [144] 0 0
Turkey
State/province [144] 0 0
Ankara
Country [145] 0 0
Turkey
State/province [145] 0 0
Istanbul
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Essex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Lancashire
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Middlesex
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Surrey
Country [150] 0 0
United Kingdom
State/province [150] 0 0
West Midlands
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Huddersfield
Country [152] 0 0
United Kingdom
State/province [152] 0 0
London
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00073528