Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments simtuzumab, gemcitabine, placebo to match simtuzumab
Phase phase 2
Sponsor Gilead Sciences
Start date November 2011
End date October 2013
Trial size 250 participants
Trial identifier NCT01472198, GS-US-324-0101

Summary

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
simtuzumab GS-6624
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
gemcitabine Gemzar®
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
(Experimental)
Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
simtuzumab GS-6624
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
gemcitabine Gemzar®
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
(Experimental)
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
simtuzumab GS-6624
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
gemcitabine Gemzar®
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
(Placebo Comparator)
Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
gemcitabine Gemzar®
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
placebo to match simtuzumab
Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Primary Outcomes

Measure
Progression free survival
time frame: Up to 3 years

Secondary Outcomes

Measure
Overall survival
time frame: Up to 3 years
Objective response
time frame: Up to 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening. - The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following: 1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR 2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either: 1. The presence of a mass in the pancreas OR 2. A history of resected pancreatic carcinoma - Measurable disease per RECIST (ver. 1.1) - ECOG Performance Status of 0 or 1. - Adequate hepatic, hematologic and renal functions. Exclusion Criteria: - A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas. - A diagnosis of pancreatic islet neoplasms. - Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization - Presence of biliary obstruction requiring external drainage - Brain metastases. - Unstable cardiovascular function within the last 6 months of screening - Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis - Known HIV infection. - Uncontrolled hypertension at Screening - History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment - Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed. - Uncontrolled systemic fungal, bacterial or viral infection - Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

Additional Information

Official title A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.