A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Phase 2

Completed

Interventions: Drug: Simtuzumab
Drug: Placebo to match simtuzumab
Drug: Gemcitabine

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo (randomized)	Placebo to match simtuzumab	Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab 700 mg (randomized)	Gemcitabine	Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab (open-label)	Simtuzumab	Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab 200 mg (randomized)	Simtuzumab	Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab (open-label)	Gemcitabine	Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab 700 mg (randomized)	Simtuzumab	Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Simtuzumab 200 mg (randomized)	Gemcitabine	Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.
Placebo (randomized)	Gemcitabine	Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.

Primary Outcome Measures

Name	Time	Method
Progression free survival	Up to 3 years	Progression free survival is measured as time from date of randomization to the earliest event time of death regardless of cause or first indication of disease progression.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 3 years	Overall survival is measured as time from date of randomization to death regardless of cause.
Objective response	Up to 3 years	Objective response is assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as complete response, partial response, stable disease, or progressive disease.

Locations (56): Birmingham Hematology and Oncology Associates, LLC
🇺🇸
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸
Mobile, Alabama, United States
Central Hematology Oncology Medical Group, Inc.
🇺🇸
Alhambra, California, United States
Comprehensive Blood and Cancer Center
🇺🇸
Bakersfield, California, United States
California Cancer Associates for Research and Excellence (CCARE)
🇺🇸
Fresno, California, United States
Pacific Shores Medical Group
🇺🇸
Long Beach, California, United States
UCLA Community Oncology Practice
🇺🇸
Los Angeles, California, United States
Stanford University Medical Center
🇺🇸
Palo Alto, California, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸
Rancho Cucamonga, California, United States
Sharp Health Care
🇺🇸
San Diego, California, United States
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Birmingham Hematology and Oncology Associates, LLC
🇺🇸Birmingham, Alabama, United States