EUCTR2010-020398-18-BEActive, not recruitingPhase 1
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas - GAMMA
Amgen Inc.0 sites825 target enrollmentStarted: December 8, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 825
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects must have histologically or cytologically confirmed metastatic
- •adenocarcinoma of the pancreas (American Joint Committee on Cancer Stage IV); ECOG score of 0 or 1; Men or women = 18 years of age.
- •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 470
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 355
Exclusion Criteria
- •Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma,
- •sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma; currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (eg, gemcitabine), radiotherapy, chemoradiotherapy or other agents for pancreatic cancer.
Investigators
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