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

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ClinicalTrials.gov Identifier: NCT01472198
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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
Pancreatic Cancer Drug: Simtuzumab Drug: Gemcitabine Drug: Placebo to match simtuzumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : February 2015

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Arms and Interventions
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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 Name: GS-6624

Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
Other Name: 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 Name: GS-6624

Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
Other Name: 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 Name: GS-6624

Drug: Gemcitabine
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
Other Name: 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 Name: 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
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 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 [ Time Frame: Up to 3 years ]
    Overall survival is measured as time from date of randomization to death regardless of cause.

  2. Objective response [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472198


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Zung Thai, MD Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01472198    
Other Study ID Numbers: GS-US-324-0101
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: February 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:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
 Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs