A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
Trial ID or NCT#
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.
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
- - 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.
- - 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
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Cancer Clinical Trials Office