Efficacy and Safety of Simtuzumab 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: September 16, 2014
Last verified: September 2014

November 9, 2011
September 16, 2014
December 2011
October 2014   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: Up to 20 months ] [ 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.
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 ]
Complete list of historical versions of study NCT01479465 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Up to 20 months ] [ Designated as safety issue: No ]
    Overall survival (OS) is measured as time from date of randomization to death regardless of cause.
  • Objective response [ Time Frame: Up to 20 months ] [ 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.
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Simtuzumab With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Simtuzumab
    Simtuzumab administered intravenously biweekly
    Other Name: GS-6624
  • Drug: FOLFIRI
    FOLFIRI administered intravenously biweekly
  • Drug: Placebo to match simtuzumab
    Placebo to match simtuzumab administered intravenously biweekly
  • Experimental: Simtuzumab 700 mg and FOLFIRI (open-label)
    Open-label, non-randomized: Participants will receive simtuzumab 700 mg followed by FOLFIRI for one cycle and continue with 28-day treatment cycles during their entire participation.
    Interventions:
    • Drug: Simtuzumab
    • Drug: FOLFIRI
  • Experimental: Simtuzumab 200 mg and FOLFIRI (randomized)
    Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of simtuzumab 200 mg followed by FOLFIRI for approximately 20 months.
    Interventions:
    • Drug: Simtuzumab
    • Drug: FOLFIRI
  • Experimental: Simtuzumab 700 mg and FOLFIRI (randomized)
    Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of simtuzumab 700 mg followed by FOLFIRI for approximately 20 months.
    Interventions:
    • Drug: Simtuzumab
    • Drug: FOLFIRI
  • Experimental: Placebo and FOLFIRI (randomized)
    Randomized, double blind, placebo-controlled portion; Participants will receive 28-day treatment cycles of placebo to match simtuzumab followed by FOLFIRI for approximately 20 months.
    Interventions:
    • Drug: FOLFIRI
    • Drug: Placebo to match simtuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
266
May 2015
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Italy,   Poland,   Russian Federation,   Spain
 
NCT01479465
GS-US-295-0203, 2011-003754-61
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Zung Thai, MD Gilead Sciences
Gilead Sciences
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP