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

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Simtuzumab — BIOLOGICAL
  SIM administered via intravenous infusion over 30 minutes
• Placebo to match SIM — DRUG
  Placebo to match SIM administered via intravenous infusion over 30 minutes
• Leucovorin — DRUG
  l-Leucovorin 200 mg/m\^2 or dl-leucovorin 400 mg/m\^2 administered via intravenous infusion over 2 hours
• Irinotecan — DRUG
  Irinotecan 180 mg/m\^2 administered via intravenous infusion over 90 minutes
• Fluorouracil — DRUG
  Fluorouracil 400 mg/m\^2 administered via intravenous bolus and 2400 mg/m\^2 via intravenous infusion over 46 hours

Study Details

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.

Key Dates

Start date

Dec 31, 2011

Status verified

Mar 2019

Primary completion

Oct 31, 2014

Completion

Feb 28, 2015

Study Design

Enrollment

266 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: FOLFIRI + SIM 700 mg (Part A)
  Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
• Experimental: FOLFIRI + SIM 200 mg (Part B)
  Participants will receive SIM 200 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
• Experimental: FOLFIRI + SIM 700 mg (Part B)
  Participants will receive SIM 700 mg via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.
• Experimental: FOLFIRI + Placebo (Part B)
  Participants will receive placebo to match SIM via intravenous infusion followed by FOLFIRI via intravenous infusion on Days 1 and 15 of each 28-day treatment cycle until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Randomization up to 27 months ]

Locations (56)

Find similar trials in Huntsville, AL

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