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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00844649




Registration number
NCT00844649
Ethics application status
Date submitted
13/02/2009
Date registered
13/02/2009
Date last updated
17/01/2017

Titles & IDs
Public title
Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
Scientific title
A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas
Secondary ID [1] 0 0
CA046
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Pancreatic Cancer 0 0
Metastatic Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Albumin-bound paclitaxel (ABI-007)
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Albumin-bound paclitaxel (ABI-007)
Treatment: Drugs - Gemcitabine

Experimental: Albumin-bound paclitaxel (ABI-007)/Gemcitabine - ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.

Active Comparator: Gemcitabine - Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).

Experimental: Albumin-bound paclitaxel (ABI-007)/Gemcitabine - ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest.

Active Comparator: Gemcitabine - Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).


Treatment: Drugs: Albumin-bound paclitaxel (ABI-007)
ABI-007 125 mg/m^2 administered by intravenous infusion

Treatment: Drugs: Gemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Treatment: Drugs: Albumin-bound paclitaxel (ABI-007)
ABI-007 125 mg/m^2 administered by intravenous infusion

Treatment: Drugs: Gemcitabine
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

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

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
Timepoint [1] 0 0
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Primary outcome [2] 0 0
Overall Survival (OS) - Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.
Timepoint [2] 0 0
From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary outcome [1] 0 0
Progression-free Survival (PFS) by Independent Radiological Review (IRR) - Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
Timepoint [1] 0 0
Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) - Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Timepoint [2] 0 0
Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS) by Independent Radiological Review (IRR) - Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.
Timepoint [3] 0 0
Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR) - Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.
Timepoint [4] 0 0
Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months

Eligibility
Key inclusion criteria
Inclusion Criteria

A participant will be eligible for inclusion in this study only if all of the following
criteria are met:

1. Participant has definitive histologically or cytologically confirmed metastatic
adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic
adenocarcinoma will be made by integrating the histopathological data within the
context of the clinical and radiographic data. Participants with islet cell neoplasms
are excluded.

2. Initial diagnosis of metastatic disease must have occurred =6 weeks prior to
randomization in the study.

3. Patient has one or more metastatic tumors measurable by Computed Tomography (CT) scan
or Magnetic resonance imaging (MRI), if patient is allergic to CT contrast media).

4. Male or non-pregnant and non-lactating female, and = 18 years of age. If a female
patient is of child-bearing potential, as evidenced by regular menstrual periods, she
must have a negative serum pregnancy test Beta-Human Chorionic Gonadotropin (ß-hCG)
documented 72 hours prior to the first administration of study drug.

If sexually active, the patient must agree to use contraception considered adequate
and appropriate by the Investigator during the period of administration of study drug.
In addition, male and female patients must utilize contraception after the end of
treatment as recommended in the product's Summary of Product Characteristics or
Prescribing Information provided in the study manual.

5. Patients must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease. Prior treatment with
5-Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer in the
adjuvant setting is allowed, provided at least 6 months have elapsed since completion
of the last dose and no lingering toxicities are present. Patients having received
cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting are
not eligible for this study.

6. Patient has adequate biological parameters as demonstrated by the following blood
counts at Baseline (obtained =14 days prior to randomization):

Absolute neutrophil count (ANC) = 1.5 × 10^9/L; Platelet count = 100,000/mm^3 (100 ×
10^9/L); Hemoglobin (Hgb) = 9 g/dL.

7. Patient has the following blood chemistry levels at Baseline (obtained =14 days prior
to randomization):

Aspartate Transaminase (AST), Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine
Transaminase ( ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) = 2.5 × upper limit of
normal range (ULN), unless liver metastases are clearly present, then = 5 × ULN is
allowed Total bilirubin = ULN Serum creatinine within normal limits or calculated
clearance = 60 mL/min/1.73 m^2 for patients with serum creatinine levels above or
below the institutional normal value. If using creatinine clearance, actual body
weight should be used for calculating creatinine clearance (e.g., using the
Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m^2, lean
body weight should be used instead.

8. Patient has acceptable coagulation studies (obtained =14 days prior to randomization)
as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within
normal limits (± 15%).

9. Patient has no clinically significant abnormalities in urinalysis results (obtained
=14 days prior to randomization).

10. Patient has a Karnofsky performance status (KPS) = 70. Two observers will be required
to assess KPS. If discrepant, the one with the lowest assessment will be considered
true.

11. Patients should be asymptomatic for jaundice prior to Day 1. Significant or
symptomatic amounts of ascites should be drained prior to Day 1. Pain symptoms should
be stable and should not require modifications in analgesic management prior to Day 1.

12. Patient has been informed about the nature of the study, and has agreed to participate
in the study, and signed the Informed Consent Form (ICF) prior to participation in any
study-related activities.
Minimum age
18 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

A patient will not be eligible for inclusion in this study if any of the following criteria
apply:

1. Patient has known brain metastases, unless previously treated and well-controlled for
at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2
scans at least 4 weeks apart).

2. Patient has only locally advanced disease.

3. Patient has experienced a =10% decrease in KPS between baseline visit and within 72
hours prior to randomization.

4. Patient has a =20% decrease in serum albumin level between baseline visit and within
72 hours prior to randomization.

5. History of malignancy in the last 5 years. Patients with prior history of in situ
cancer or basal or squamous cell skin cancer are eligible. Patients with other
malignancies are eligible if they were cured by surgery alone or surgery plus
radiotherapy and have been continuously disease-free for at least 5 years.

6. Patient uses Coumadin.

7. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy.

8. Patient has known historical or active infection with Human Immunodeficiency Virus
(HIV), hepatitis B, or hepatitis C.

9. Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done
to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to
Day 1 of treatment in this study.

10. Patient has a history of allergy or hypersensitivity to any of the study drugs or any
of their excipients, or the patient exhibits any of the events outlined in the
Contraindications or Special Warnings and Precautions sections of the product or
comparator Summary of Product Characteristics (SmPC) or Prescribing Information.

11. History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa).

12. Patients with a history of interstitial lung disease.

13. History of chronic leukemias (e.g., chronic lymphocytic leukemia).

14. Patients with high cardiovascular risk, including, but not limited to, recent coronary
stenting or myocardial infarction in the past year.

15. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

16. Patient has serious medical risk factors involving any of the major organ systems, or
serious psychiatric disorders, which could compromise the patient's safety or the
study data integrity.

17. Patient is enrolled in any other clinical protocol or investigational trial.

18. Patient is unwilling or unable to comply with study procedures, or is planning to take
vacation for 7 or more consecutive days during the course of the study.

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
Open (masking not 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,TAS,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Macarthur Cancer Therapy Center - Campbelltown
Recruitment hospital [3] 0 0
Concord Hospital - Concord
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 0 0
Newcastle Hospital - Waratah
Recruitment hospital [7] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [8] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [9] 0 0
Haemotology & Oncology Australasia (HOCA) - Milton
Recruitment hospital [10] 0 0
Haematology Oncology Clinics of Australasia-Gold Coast - Milton
Recruitment hospital [11] 0 0
Adelaide Cancer Centre (T/A Ashford Cancer Ctr) - Ashford
Recruitment hospital [12] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [13] 0 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [14] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [15] 0 0
Medical Oncology Unit, Bendigo Health - Bendigo
Recruitment hospital [16] 0 0
Monash Medical Centre - East Bentleigh
Recruitment hospital [17] 0 0
Western Hospital - Footscray
Recruitment hospital [18] 0 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [19] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [20] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [21] 0 0
Sir Charles Gairdner Hospital - Nedlands, Perth
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
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2031 - Randwick
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2298 - Waratah
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
4101 - Milton
Recruitment postcode(s) [10] 0 0
4215 - Milton
Recruitment postcode(s) [11] 0 0
5035 - Ashford
Recruitment postcode(s) [12] 0 0
5042 - Bedford Park
Recruitment postcode(s) [13] 0 0
5006 - North Adelaide
Recruitment postcode(s) [14] 0 0
7000 - Hobart
Recruitment postcode(s) [15] 0 0
3552 - Bendigo
Recruitment postcode(s) [16] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [17] 0 0
3011 - Footscray
Recruitment postcode(s) [18] 0 0
3199 - Frankston
Recruitment postcode(s) [19] 0 0
3004 - Melbourne
Recruitment postcode(s) [20] 0 0
3690 - Wodonga
Recruitment postcode(s) [21] 0 0
6009 - Nedlands, Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Mexico
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New York
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North Carolina
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Utah
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Washington
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Wisconsin
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Austria
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Linz
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Austria
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St. Pölten
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Vienna
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Wels
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Kortrijk
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Roeselare
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Canada
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Alberta
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Ontario
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Montreal
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France
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Angers
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Essen
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Oldenburg
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Bari
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Milano
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Padova
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Pavia
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Italy
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Pisa
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Reggio Emilia
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Roma
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Rozzano
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Italy
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San Giovanni Rotondo, Foggia
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Italy
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Verona
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Russian Federation
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Kaluga Region
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Russian Federation
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Republic of Tatarstan
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ivanovo
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Russian Federation
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Magnitogorsk
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Moscow Region
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Moscow
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Russian Federation
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Omsk
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Orenburg
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Pyatigorsk
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Russian Federation
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St Petersburg
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St. Petersburg
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Russian Federation
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Tula
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Russian Federation
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Ufa
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Russian Federation
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Yaroslavl
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Sevilla
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Ukraine
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UK
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Ukraine
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Kharkov
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Ukraine
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Kherson
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Ukraine
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Odessa
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Ukraine
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Zaporizhia

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

Ethics approval
Ethics application status

Summary
Brief summary
Phase III Metastatic Pancreatic Cancer
Trial website
https://clinicaltrials.gov/show/NCT00844649
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Von Hoff, MD
Address 0 0
Scottsdale Clinical Research Institute
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