Study Complete
Sponsor ID
20060323

A Study of AMG 655 or AMG 479 in Combination with Gemcitabine for Treatment of Metastatic Pancreatic Cancer

Sponsor ID
20060323
Clinicaltrials.gov ID
NCT00630552
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.

Additional Study Details

Phase
Phase 1/Phase 2
Product
conatumumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
138
Additional Study Details

Protocol Summary

Primary Outcome Measures

Survival

Timeframe: 6 months

Safety

Timeframe: Length of the study

Secondary Outcome Measures

Safety and Efficacy Endpoints

Timeframe: Length of the study

Overall Survival

Timeframe: Length of the study

Time to Response

Timeframe: Length of the study

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Boston, MA, United States, 02215
Status
Completed
Location
Research Site
Chicago, IL, United States, 60637
Status
Completed
Location
Research Site
Greenville, SC, United States, 29615
Status
Completed
Location
Research Site
Albany, NY, United States, 12206
Status
Completed
Location
Research Site
Dallas, TX, United States, 75246
Status
Completed
Location
Research Site
Durham, NC, United States, 27710
Status
Completed
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