Efficacy and Safety of GS-6624 With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01479465
First received: November 9, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This randomized study compares the efficacy of GS-6624 versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS or BRAF mutant colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: GS-6624
Drug: FOLFIRI
Drug: Placebo to match GS-6624
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-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen.

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Baseline to Month 20 ] [ Designated as safety issue: No ]
    Progression free survival (PFS) is measured as the time from date of randomization to the earliest (event) time of either death regardless of cause or first indication of disease progression.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Baseline to Month 20 ] [ Designated as safety issue: No ]
    Overall survival (OS) is measured as time from date of randomization to death regardless of cause.

  • Objective response rate [ Time Frame: Baseline to Month 20 ] [ 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.


Estimated Enrollment: 265
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-6624 700 mg and FOLFIRI (open-label)
Open-label, 28-day treatment period performed to assess the safety and tolerability prior to beginning the randomized part of the study; Participants will receive GS-6624 700 mg followed by FOLFIRI for one cycle and continue with 28-day treatment cycles during their entire participation.
Drug: GS-6624
GS-6624 200 mg or 700 mg administered intravenously biweekly
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Experimental: GS-6624 200 mg and FORFIRI (randomized)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of 200 mg GS-6624 followed by FOLFIRI for approximately 20 months.
Drug: GS-6624
GS-6624 200 mg or 700 mg administered intravenously biweekly
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Experimental: GS-6624 700 mg and FOLFIRI (randomized)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of 700 mg GS-6624 followed by FOLFIRI for approximately 20 months.
Drug: GS-6624
GS-6624 200 mg or 700 mg administered intravenously biweekly
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Experimental: Placebo and FOLFIRI (randomized)
Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of placebo to match GS-6624 followed by FOLFIRI for approximately 20 months.
Drug: FOLFIRI
FOLFIRI administered intravenously biweekly
Drug: Placebo to match GS-6624
Placebo to match GS-6624 administered intravenously biweekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic Colorectal Carcinoma with KRAS mutation.
  • Received first line therapy and discontinued part or all of first line therapy.
  • Estimated life expectancy > 3 months.
  • Stage IV disease.
  • Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Adequate hepatic and hematologic function
  • No major operations within 4 weeks prior to treatment start.

Exclusion Criteria:

  • More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.
  • Experimental medical treatment within 30 days prior to study entry.
  • Known or suspected cerebral metastases.
  • History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment.
  • Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).
  • Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities consistent with ischemia.
  • Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
  • Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis.
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
  • Prior irinotecan therapy for metastatic disease is not permitted.
  • Systemic fungal, bacterial, viral, or other infection.
  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: NCT01479465

  Show 109 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: NCT01479465     History of Changes
Other Study ID Numbers: GS-US-295-0203, 2011-003754-61
Study First Received: November 9, 2011
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
GSI
Gilead
Gilead Sciences
GS-6624
Colorectal Cancer
KRAS
Oncology
monoclonal antibody

Additional relevant MeSH terms:
Adenocarcinoma
Colorectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 18, 2014