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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472198
• Other study ID #: GS-US-324-0101
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2011
• Last updated: February 19, 2015
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2015
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Simtuzumab
Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
• Gemcitabine
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
• Placebo to match simtuzumab
Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Locations

Country	Name	City	State
Russian Federation	State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"	Arkhangelsk	Primorskiy
Russian Federation	Regional Oncology Dispensary	Ivanovo
Russian Federation	Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan	Kazan	Tatarstan
Russian Federation	Kursk Regional Oncologic Dispensary	Kursk
Russian Federation	Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology	Moscow
Russian Federation	Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway	Moscow
Russian Federation	Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD	Moscow
Russian Federation	State Institution "Blokhin Cancer Research Centre RAMS"	Moscow
Russian Federation	State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary"	Nizhny Novgorod
Russian Federation	Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk	Obninsk	Kaluga
Russian Federation	Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"	Omsk
Russian Federation	Petrov Research Oncology Institute	Saint Petersburg
Russian Federation	Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan	Ufa	Bashkortostan
United States	Central Hematology Oncology Medical Group, Inc.	Alhambra	California
United States	Anne Arundel Medical Center, Annapolis Oncology Center	Annapolis	Maryland
United States	Georgia Cancer Specialists, P.C.	Atlanta	Georgia
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	Oncology Hematology Care, Inc.	Blue Ash	Ohio
United States	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	Coastal Bend Cancer Center	Corpus Christi	Texas
United States	Oncology Hematology Care, Inc.	Crestview Hills	Kentucky
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Duke University Medical Center, Comprehensive Cancer Center	Durham	North Carolina
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas
United States	Center for Cancer and Blood Disorders, PC	Fort Worth	Texas
United States	California Cancer Associates for Research and Excellence (CCARE)	Fresno	California
United States	Saint Mary's Regional Cancer Center	Grand Junction	Colorado
United States	PinnacleHealth	Harrisburg	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Emerywood Hematology and Oncology	High Point	North Carolina
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	Pacific Shores Medical Group	Long Beach	California
United States	UCLA Community Oncology Practice	Los Angeles	California
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Montana Cancer Institute Foundation c/o Montana Cancer Specialists	Missoula	Montana
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Beth Israel Comprehensive Cancer Center	New York	New York
United States	Saint Luke's-Roosevelt Hospital Center	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Wilshire Oncology Medical Group, Inc.	Rancho Cucamonga	California
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Saint Joseph Oncology, Inc.	Saint Joseph	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Sharp Health Care	San Diego	California
United States	San Jose Medical Group	San Jose	California
United States	Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland	Southfield	Michigan
United States	Hematology Oncology Associates, PC	Stamford	Connecticut
United States	Florida Cancer Specialists	Tampa	Florida
United States	Hematology and Oncology Associates at BridgePoint	Tupelo	Mississippi
United States	Abington Hematology Oncology Associates, Inc.	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall survival	Overall survival is measured as time from date of randomization to death regardless of cause.	Up to 3 years	No
Secondary	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	No