A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
18 Years
N/A
Both
Adenocarcinoma of the Pancreas, Locally Advanced, Unresectable
Trial Information
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of AMG 479 or Placebo in Combination With Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas
This study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled
trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for
locally advanced unresectable adenocarinoma of the pancreas. Approximately 150 subjects
will be randomized in a 1:1 ratio to AMG 479 and gemcitabine, or gemcitabine and placebo.
Randomization will be stratified by ECOG (0 or 1).
Gemcitabine will be given on days 1, 8, and 15, followed by AMG 479 on days 1 and 15 of
every 28 day cycle. Treatment will continue until radiographic disease progression,
unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.
Inclusion Criteria:
- Subjects must have histologically or cytologically confirmed locally advanced
adenocarcinoma of the pancreas that is unresectable, per institutional practice
- Radiologically measurable and/or non-measurable disease as defined by RECIST version
1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women >/= 18 years of age
- Adequate organ function
Exclusion Criteria:
- Early (stage I) or metastatic (stage IV) disease
- Islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc),
adenocarcinoma originating from biliary tree or cystadenocarcinoma
- External biliary drain
- Currently treated or previously treated with biologic, small molecule, immunotherapy,
chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer
- Currently treated or previously treated with radiotherapy, or chemoradiotherapy for
pancreatic cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
The primary endpoint is progression-free survival (PFS) as defined as the time from randomization to progression (per RECIST v1.1) or death.
Outcome Time Frame:
Approximately 23 months
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
20080261
NCT ID:
NCT01318642
Start Date:
May 2012
Completion Date:
December 2012
Related Keywords:
- Adenocarcinoma of the Pancreas
- Locally Advanced
- Unresectable
- Adenocarcinoma
- pancreas
- pancreatic cancer
- local
- unresectable
- stage II
- stage III
- Adenocarcinoma
- Adenocarcinoma, Mucinous
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Chattanooga, Tennessee |
