Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

Part of paid clinical trials in Bakersfield, California.

Sponsor
Genentech, Inc.
Study ID
NCT01652482
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-fluorouracil — DRUG
    Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter \[mg/m\^2\] administered as intravenous bolus and then 5-FU 2400 mg/m\^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
  • Cetuximab — DRUG
    Cetuximab 400 mg/m\^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m\^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity.
  • Irinotecan — DRUG
    Standard Irinotecan chemotherapy (180 milligram per square meter \[mg/m\^2\] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
  • Leucovorin — DRUG
    Standard Leucovorin chemotherapy (400 mg/m\^2 \[racemic form\] or 200 mg/m\^2 \[L-isomer form\] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
  • MEHD7945A — DRUG
    MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity.

Study Details

This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid \[leucovorin\], 5-fluorouracil \[5-FU\], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Key Dates

Start date
Oct 31, 2012
Status verified
Nov 2016
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFIRI + Cetuximab
  • Experimental: FOLFIRI + MEHD7945A

Primary Outcome Measure

Progression-free Survival (PFS) According to Modified RECIST v1.1 Criteria [ Time Frame: approximately 2 year ]

Locations (19)

FacilityCityStateZIPSite coordinators
-BakersfieldCalifornia93309-
-FullertonCalifornia92835-
-Los AngelesCalifornia90033-
-Los AngelesCalifornia90095-
-San Luis ObispoCalifornia93454-
-Santa BarbaraCalifornia93105-
-AuroraColorado80045-
-Orange ParkFlorida32073-
-HarveyIllinois60426-
-PaducahKentucky42003-
-RockvilleMaryland20850-
-BostonMassachusetts02114-
-BostonMassachusetts02215-
-DetroitMichigan48201-
-Jefferson CityMissouri65109-
-Las VegasNevada89148-
-PhiladelphiaPennsylvania19104-
-KirklandWashington98034-
-SeattleWashington98109-

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By condition
Colorectal cancer
By specialty
OncologyGI oncology

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