A Study To Evaluate The Efficacy And Safety Of Simtuzumab Combined With Gemcitabine For Metastatic Pancreatic Adenocarcinoma

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: Simtuzumab
DRUG: Gemcitabine
DRUG: Placebo to match simtuzumab

GS-US-324-0101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-11-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-02-19
First Submitted that Met QC Criteria 2011-11-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-03-10
First Posted (ESTIMATED) 2011-11-16	Results First Posted N/A	Last Verified 2015-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Triple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Simtuzumab (open-label) Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.	DRUG: Simtuzumab Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15) DRUG: Gemcitabine Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
EXPERIMENTAL: Simtuzumab 200 mg (randomized) Participants will receive simtuzumab 200 mg plus gemcitabine in cycles of 28 days for up to 3 years.	DRUG: Simtuzumab Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15) DRUG: Gemcitabine Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
EXPERIMENTAL: Simtuzumab 700 mg (randomized) Participants will receive simtuzumab 700 mg plus gemcitabine in cycles of 28 days for up to 3 years.	DRUG: Simtuzumab Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15) DRUG: Gemcitabine Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
PLACEBO_COMPARATOR: Placebo (randomized) Participants will receive placebo to match simtuzumab plus gemcitabine in cycles of 28 days for up to 3 years.	DRUG: Gemcitabine Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle DRUG: Placebo to match simtuzumab Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Primary Outcome Measures	Measure Description	Time Frame
Progression free survival	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.	Up to 3 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival	Overall survival is measured as time from date of randomization to death regardless of cause.	Up to 3 years
Objective response	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.	Up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Zung Thai, MD, Gilead Sciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Benson AB 3rd, Wainberg ZA, Hecht JR, Vyushkov D, Dong H, Bendell J, Kudrik F. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab or Placebo in Combination with Gemcitabine for the First-Line Treatment of Pancreatic Adenocarcinoma. Oncologist. 2017 Mar;22(3):241-e15. doi: 10.1634/theoncologist.2017-0024. Epub 2017 Feb 28.

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Resources

PatientS

Caregivers

Clinical Trial Record