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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01472198
First received: November 10, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Overall survival is measured as time from date of randomization to death regardless of cause.

  • Objective response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 250
Study Start Date: November 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472198

  Show 57 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Zung Thai, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01472198     History of Changes
Other Study ID Numbers: GS-US-324-0101
Study First Received: November 10, 2011
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

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
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014