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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01472198
Collaborator
(none)
250
Enrollment
57
Locations
4
Arms
39
Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

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)
Other Names:
  • GS-6624

    • Drug: Gemcitabine
    Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
    Other Names:
  • Gemzar®

    		•
    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)
    Other Names:
  • GS-6624

    • Drug: Gemcitabine
    Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
    Other Names:
  • Gemzar®

    		•
    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)
    Other Names:
  • GS-6624

    • Drug: Gemcitabine
    Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
    Other Names:
  • Gemzar®

    		•
    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
    Other Names:
  • Gemzar®

    • Drug: Placebo to match simtuzumab
    Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall survival [Up to 3 years]

      Overall survival is measured as time from date of randomization to death regardless of cause.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    3. The presence of a mass in the pancreas OR

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Hematology and Oncology Associates, LLC Birmingham Alabama United States
    2 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36604
    3 Central Hematology Oncology Medical Group, Inc. Alhambra California United States
    4 Comprehensive Blood and Cancer Center Bakersfield California United States
    5 California Cancer Associates for Research and Excellence (CCARE) Fresno California United States 93720
    6 Pacific Shores Medical Group Long Beach California United States
    7 UCLA Community Oncology Practice Los Angeles California United States
    8 Stanford University Medical Center Palo Alto California United States
    9 Wilshire Oncology Medical Group, Inc. Rancho Cucamonga California United States 91730
    10 Sharp Health Care San Diego California United States 92123
    11 San Jose Medical Group San Jose California United States 95116
    12 Saint Mary's Regional Cancer Center Grand Junction Colorado United States
    13 Hematology Oncology Associates, PC Stamford Connecticut United States
    14 Florida Cancer Specialists Tampa Florida United States 33607
    15 Georgia Cancer Specialists, P.C. Atlanta Georgia United States 30341
    16 Northwestern University Chicago Illinois United States
    17 Oncology Hematology Care, Inc. Crestview Hills Kentucky United States 41017
    18 Anne Arundel Medical Center, Annapolis Oncology Center Annapolis Maryland United States
    19 West Michigan Cancer Center Kalamazoo Michigan United States
    20 Providence Cancer Center Oncology and Hematology Care Clinic-Eastside Portland Southfield Michigan United States 48075
    21 Hematology and Oncology Associates at BridgePoint Tupelo Mississippi United States
    22 Saint Joseph Oncology, Inc. Saint Joseph Missouri United States
    23 Washington University School of Medicine Saint Louis Missouri United States 63108
    24 Montana Cancer Institute Foundation c/o Montana Cancer Specialists Missoula Montana United States
    25 Comprehensive Cancer Centers of Nevada Henderson Nevada United States
    26 Saint Luke's-Roosevelt Hospital Center New York New York United States 10003
    27 Beth Israel Comprehensive Cancer Center New York New York United States
    28 Duke University Medical Center, Comprehensive Cancer Center Durham North Carolina United States
    29 Emerywood Hematology and Oncology High Point North Carolina United States
    30 Oncology Hematology Care, Inc. Blue Ash Ohio United States 45242
    31 PinnacleHealth Harrisburg Pennsylvania United States 17109
    32 Abington Hematology Oncology Associates, Inc. Willow Grove Pennsylvania United States 19090
    33 Charleston Hematology Oncology Associates, PA Charleston South Carolina United States
    34 South Carolina Oncology Associates Columbia South Carolina United States
    35 Tennessee Cancer Specialists Knoxville Tennessee United States
    36 Tennessee Oncology, PLLC Nashville Tennessee United States 37206
    37 Coastal Bend Cancer Center Corpus Christi Texas United States
    38 University of Texas Southwestern Medical Center at Dallas Dallas Texas United States
    39 San Antonio Military Medical Center Fort Sam Houston Texas United States 78234
    40 Center for Cancer and Blood Disorders, PC Fort Worth Texas United States
    41 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States
    42 Utah Cancer Specialists Salt Lake City Utah United States 84106
    43 Virginia Cancer Specialists, PC Fairfax Virginia United States
    44 Virginia Cancer Institute Richmond Virginia United States
    45 Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan Ufa Bashkortostan Russian Federation 450054
    46 Medical Radiological Research Center of Russian Academy of Medical Sciences, Obninsk Obninsk Kaluga Russian Federation 249036
    47 State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary" Arkhangelsk Primorskiy Russian Federation 163045
    48 Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan Kazan Tatarstan Russian Federation 420029
    49 Regional Oncology Dispensary Ivanovo Russian Federation 153040
    50 Kursk Regional Oncologic Dispensary Kursk Russian Federation 305035
    51 Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology Moscow Russian Federation 115478
    52 State Institution "Blokhin Cancer Research Centre RAMS" Moscow Russian Federation 115478
    53 Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD Moscow Russian Federation 125367
    54 Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway Moscow Russian Federation 129128
    55 State Budgetary Healthcare Institution "Nizhny Novgorod Regional Oncological Dispensary" Nizhny Novgorod Russian Federation 603081
    56 Budgetary Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary" Omsk Russian Federation 644013
    57 Petrov Research Oncology Institute Saint Petersburg Russian Federation 197758

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Zung Thai, MD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01472198
    Other Study ID Numbers:
    • GS-US-324-0101
    First Posted:
    Nov 16, 2011
    Last Update Posted:
    Mar 10, 2015
    Last Verified:
    Feb 1, 2015
    Keywords provided by Gilead Sciences
    GSI
    Gilead
    Gilead Sciences
    Pancreatic Cancer
    PC
    Gemcitabine
    Phase 2
    Phase II
    GS-6624
    Oncology
    Monoclonal Antibody
    Additional relevant MeSH terms:
    Adenocarcinoma
    Pancreatic Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Mar 10, 2015