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NCT01479465 Clinical Trial

Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01479465
Other study ID # GS-US-295-0203
Secondary ID 2011-003754-61
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 2011
Est. completion date February 2015

Study information
Verified date March 2019
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

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Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Simtuzumab
SIM administered via intravenous infusion over 30 minutes
Drug:
• Placebo to match SIM
Placebo to match SIM administered via intravenous infusion over 30 minutes
• Leucovorin
l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
• Irinotecan
Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
• Fluorouracil
Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
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Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Poland,  Russian Federation,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates. Randomization up to 27 months
Secondary Overall Survival (OS) The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates. Randomization up to 33 months
Secondary Objective Response Rate (ORR) Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR. Randomization up to 27 months
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