A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
Recruiting in Palo Alto (17 mi)
+56 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Gilead Sciences
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
ECOG Performance Status of 0 or 1.
Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR The presence of a mass in the pancreas OR A history of resected pancreatic carcinoma
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Treatment Details
Interventions
- Gemcitabine (Anti-metabolites)
- Placebo to match simtuzumab (Placebo)
- Simtuzumab (Monoclonal Antibodies)
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Simtuzumab 700 mg (randomized)Experimental Treatment2 Interventions
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Group II: Simtuzumab 200 mg (randomized)Experimental Treatment2 Interventions
Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Group III: Simtuzumab (open-label)Experimental Treatment2 Interventions
Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Group IV: Placebo (randomized)Placebo Group2 Interventions
Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇺🇸 Approved in United States as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇨🇦 Approved in Canada as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇯🇵 Approved in Japan as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
Montana Cancer Institute Foundation c/o Montana Cancer SpecialistsMissoula, MT
Comprehensive Cancer Centers of NevadaHenderson, NV
Oncology Hematology Care, Inc.Blue Ash, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Gilead SciencesLead Sponsor