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A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma
Trial ID: NCT01472198
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
- 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
- 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
drug: Placebo to match simtuzumab
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