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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01015118




Registration number
NCT01015118
Ethics application status
Date submitted
9/11/2009
Date registered
18/11/2009
Date last updated
7/12/2017

Titles & IDs
Public title
LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
Scientific title
Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
Secondary ID [1] 0 0
AGO-OVAR12
Secondary ID [2] 0 0
1199.15
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Peritoneal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Paclitaxel
Treatment: Drugs - BIBF 1120
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin

Experimental: BIBF 1120 - patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel

Placebo Comparator: Placebo - patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel


Treatment: Drugs: Placebo
comparator to BIBF 1120

Treatment: Drugs: Paclitaxel
Paclitaxel (standard chemo-therapy)

Treatment: Drugs: BIBF 1120
comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)

Treatment: Drugs: Carboplatin
Carboplatin (standard chemo-therapy)

Treatment: Drugs: Paclitaxel
Paclitaxel (standard chemo-therapy)

Treatment: Drugs: Carboplatin
Carboplatin (standard chemo-therapy)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria. - Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.
The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Timepoint [1] 0 0
First drug administration to date of disease progression or death whichever occurs first , upto 29 months
Primary outcome [2] 0 0
PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis). - Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Timepoint [2] 0 0
First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
Secondary outcome [1] 0 0
PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint). - Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.
The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Timepoint [1] 0 0
First drug administration to date of disease progression or death whichever occurs first , upto 29 months
Secondary outcome [2] 0 0
PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis). - Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Timepoint [2] 0 0
First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months
Secondary outcome [3] 0 0
Overall Survival - Overall survival is defined as time from randomization to date of death (irrespective of reason).
Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Timepoint [3] 0 0
First drug administration to date of death until final DBL 26September16, upto 62 months
Secondary outcome [4] 0 0
Time to CA-125 Tumour Marker Progression - Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > Upper limit of normal (ULN) or CA-125 >=2 x ULN in case nadir value <= ULN.
Timepoint [4] 0 0
First drug administration until final DBL 26September16, upto 62 months
Secondary outcome [5] 0 0
Objective Response Based on Investigator Assessment - Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline
Timepoint [5] 0 0
First drug administration until final DBL 26September16, upto 62 months
Secondary outcome [6] 0 0
Change in Abdominal/Gastro-intestinal Symptoms Over Time - Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).
As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).
Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).
Timepoint [6] 0 0
First drug administration until final DBL 26September16, upto 62 months
Secondary outcome [7] 0 0
Change in Global Health Status/ Quality of Life (QoL) Scale Over Time. - Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.
As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).
Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB-III vs IV), and Carboplatin level (AUC5 vs. AUC6).
Timepoint [7] 0 0
First drug administration until final DBL 26September16, upto 62 months

Eligibility
Key inclusion criteria
Inclusion criteria:

- first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube
or primary peritoneal cancer

- International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV

- females, age 18 years or older

- life expectancy of at least 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- prior surgery, defined as either (a) debulking surgery with maximum surgical effort at
cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in
patients with stage IV disease for whom surgical debulking was not considered
appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to
disease progression (including interval debulking surgery)

- patient has given written informed consent which must be consistent with the
International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local
legislation

- planned application of first dose of chemotherapy after wound healing, but no later
than 10 weeks after surgery
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- histologic diagnosis of a benign or borderline tumour or of a malignant tumour of
non-epithelial origin of the ovary, the fallopian tube or the peritoneum

- planned surgery within 124 weeks after randomisation in this trial, including interval
debulking surgery

- clinically relevant non-healing wound, ulcer or bone fracture

- clinical symptoms or signs of gastrointestinal obstruction that require parenteral
nutrition or hydration

- brain metastases

- pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse
Events (CTCAE) grade 2 or higher, except due to trauma

- history of major thromboembolic event

- known inherited or acquired bleeding disorder

- significant cardiovascular diseases

- clinically relevant pericardial effusion

- history of a cerebral vascular accident, transient ischemic attack or subarachnoid
haemorrhage within the past 6 months

- inadequate safety laboratory values

- serious infections in particular if requiring systemic antibiotic (antimicrobial,
antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human
Immunodeficiency Virus (HIV)

- poorly controlled diabetes mellitus or other contraindication to high dose
corticosteroid therapy

- gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug

- other malignancy diagnosed within the past 5 years. In exception to this rule, the
following malignancies may be included if adequately treated: non-melanomatous skin
cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk
endometrial cancer

- prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody
therapy, oral targeted therapy, hormonal therapy)

- prior systemic cytotoxic chemotherapy

- prior treatment with BIBF 1120 or any other angiogenesis inhibitor

- prior radiotherapy

- serious illness or concomitant non-oncological disease such as neurologic, psychiatric
or infectious disease or a laboratory abnormality that may increase the risk
associated with study participation or study drug administration

- Women of childbearing potential who are sexually active and not using a highly
effective method of birth control during the trial and for at least twelve months
after the end of active therapy.

- pregnancy or breast feeding

- psychological, familial, sociological or geographical factors potentially hampering
compliance with the study protocol and follow-up schedule

- active alcohol or drug abuse

- patients unable to comply with the protocol

- any contraindications for therapy with paclitaxel or carboplatin

- treatment with other investigational drugs or participation in another clinical trial
testing a drug within the past four weeks before start of therapy or concomitantly
with this trial

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?



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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
1199.15.61006 Boehringer Ingelheim Investigational Site - Camperdown
Recruitment hospital [2] 0 0
1199.15.61001 Boehringer Ingelheim Investigational Site - Waratah
Recruitment hospital [3] 0 0
1199.15.61004 Boehringer Ingelheim Investigational Site - Herston
Recruitment hospital [4] 0 0
1199.15.61003 Boehringer Ingelheim Investigational Site - Southe Brisbane
Recruitment hospital [5] 0 0
1199.15.61005 Boehringer Ingelheim Investigational Site - North Terrace
Recruitment hospital [6] 0 0
1199.15.61007 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [7] 0 0
1199.15.61002 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Waratah
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Southe Brisbane
Recruitment postcode(s) [5] 0 0
- North Terrace
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Nedlands
Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Louisiana
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Michigan
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Washington
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Graz
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Innsbruck
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Krems
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Edegem
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Offenbach
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Solingen
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Stadthagen
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Stendal
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Ulm
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Viersen
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Wiesbaden
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Witten
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Worms
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Athens
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Heraklio
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Patras
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Asti
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Catania
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and
carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in
first-line treatment of patients with advanced ovarian cancer. Safety information about
BIBF1120/paclitaxel/carboplatin will be obtained.
Trial website
https://clinicaltrials.gov/show/NCT01015118
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications