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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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29 May 2012 |
Main ID: |
EUCTR2007-001568-66-IT |
Date of registration:
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27/02/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A RANDOMIZED, DOUBLE BLIND PHASE 3 STUDY OF GEMCITABINE PLUS AG 013736 VERSUS GEMCITABINE PLUS PLACEBO FOR THE FIRST LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC PANCREATIC CANCER - ND
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Scientific title:
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A RANDOMIZED, DOUBLE BLIND PHASE 3 STUDY OF GEMCITABINE PLUS AG 013736 VERSUS GEMCITABINE PLUS PLACEBO FOR THE FIRST LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC PANCREATIC CANCER - ND |
Date of first enrolment:
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28/01/2008 |
Target sample size:
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596 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001568-66 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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France
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Germany
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Hungary
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Ireland
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Italy
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Portugal
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection. 2. Adequate hepatic and renal function documented within 14 days prior to treatment as documented by: AST and ALT 2.5 x upper limit of normal (ULN), Total bilirubin 1.0 x ULN Serum creatinine 1.5 x ULN or calculated creatinine clearance 60 mL/min Urinary protein <1+ 3. Adequate bone marrow function as defined by: ANC 1500 cells/mm3 platelets 100,000 cells/mm3 hemoglobin 9 g/dL 4. Male or female, age 18 years. 5. ECOG performance status of 0 or 1 (see Appendix D) 6. Life expectancy of ≥12 weeks. 7. Resolution of all acute toxic effects of prior radiotherapy, or surgical procedure to NCI CTCAE Grade 8. No evidence of preexisting uncontrolled hypertension Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Prior treatment with any systemic chemotherapy for metastatic disease. 2. Prior adjuvant chemotherapy or radiotherapy <4 weeks before starting the study treatment. 3. Prior treatment with gemcitabine, AG 013736, or other VEGF inhibitors. 4. Current or recent (within 1 month) use of a thrombolytic agent. 5. Central lung lesions involving major blood vessels. 6. History of hemoptysis > œ tsp of bright red blood per day within past 1 week. 7. Gastrointestinal abnormalities 8. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors 9. Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers. 10. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. 11. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment. 12. Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism. 13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness. 14. History of a malignancy 15. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of treatment.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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locally advanced, unresectable or metastatic pancreatic cancer MedDRA version: 9.1
Level: LLT
Classification code 10033611
Term: Pancreatic carcinoma non-resectable
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Intervention(s)
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Product Name: Axitinib Product Code: AG-013736 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Axitinib CAS Number: 319460-85-0 Current Sponsor code: AG-013736 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: Axitinib Product Code: AG-013736 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Axitinib CAS Number: 319460-85-0 Current Sponsor code: AG-013736 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: Compare the progression free survival (PFS) of patients in each arm Compare the objective response rate (ORR) of patients in each arm Estimate the duration of response (DR) of patients in each arm Evaluate the safety and tolerability of AG 013736 plus gemcitabine Compare the health related quality of life (HRQOL), pain ratings, and health status of patients in each arm as measured by the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire Core 30 (EORTC QLQ C30) and Pancreatic 26 (PAN26) (see Appendix A), BPI sf (see Appendix B), and EQ 5D (see Appendix C) Conduct population pharmacokinetic analysis using AG 013736 plasma concentrations
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Main Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG 013736 versus gemcitabine plus placebo.
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Primary end point(s): Primary: OS Overall survival Secondary 1. PFS 2. ORR 3. DR 4. Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0), timing, seriousness, and relatedness of adverse events, and laboratory abnormalities 5. PROs: EORTC QLQ C30, QLQ PAN26, BPI sf, EQ 5D 6. AG 013736 population pharmacokinetic analysis
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Secondary ID(s)
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2007-001568-66-IE
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A4061028
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Source(s) of Monetary Support
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Results
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Results available:
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