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A Study to Evaluate the Efficacy and Safety of GS-6624 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: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

This randomized study compares the efficacy of GS-6624 versus placebo in combination with Gemcitabine in subjects with Pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
 Drug: GS-6624
Drug: Placebo
Drug: Gemcitabine
 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:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 244
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 700 mg GS-6624 and Gemcitabine (open-label)
Open label, non-randomized treatment period to assess the safety and tolerability of GS-6624 dosed at 700 mg in combination with intravenous (IV) Gemcitabine
 Drug: GS-6624
700 mg of GS-6624 dosed weekly
Drug: Gemcitabine
dosed weekly for three weeks at a time
Experimental: 200 mg GS-6624 and Gemcitabine (randomized)
Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) Gemcitabine.
 Drug: GS-6624
200 mg of GS-6624 dosed weekly
Drug: Gemcitabine
dosed weekly for three weeks at a time
Experimental: 700 mg GS-6624 and Gemcitabine (randomized)
Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) Gemcitabine.
 Drug: Gemcitabine
dosed weekly for three weeks at a time
Drug: GS-6624
700 mg of GS-6624 dosed weekly
Experimental: Placebo and Gemcitabine (randomized)
Randomized, double- blinded, placebo-controlled portion of the trial for subjects randomized to 200 mg GS-6624, 700 mg GS-6624, or placebo in combination with intravenous (IV) Gemcitabine.
 Drug: Placebo
Placebo - dosed weekly
Drug: Gemcitabine
dosed weekly for three weeks at a time

Detailed Description:

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

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

  Show 57 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Mike Hawkins, M.D. 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: May 21, 2013
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
Adenocarcinoma, Mucinous
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
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 May 23, 2013