Phase I/II Combination With Irinotecan- Erbitux

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00594984
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer (MCRC)

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
    IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression
  • Irinotecan — DRUG
    IV solution, IV, Q3W, 350 mg/m2, until progression
  • Brivanib — DRUG
    Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression
  • Brivanib — DRUG
    Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression
  • Brivanib Placebo — DRUG
    Oral, tablet, QD, until progression

Study Details

Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC) Part 2: To compare median duration of progression free survival (PFS)

Key Dates

Start date
May 31, 2008
Status verified
Oct 2015
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Active Comparator: Arm 1 - Phase 1
    Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo
  • Placebo Comparator: Arm 2 - Phase 2
    Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo

Primary Outcome Measure

Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial [ Time Frame: PK C1D1-C2-D3, biomarker throughout the study ]

Locations (4)

FacilityCityStateZIPSite coordinators
Usc/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Usc/Norris Comprehensive Cancer Center HospitalLos AngelesCalifornia90033-
James Graham Brown Cancer CenterLouisvilleKentucky40202-
Washington UniversitySt LouisMissouri63110-

Find similar trials in Los Angeles, CA

By research site
Usc/Norris Comprehensive Cancer Center· Los Angeles, CAUsc/Norris Comprehensive Cancer Center Hospital· Los Angeles, CAJames Graham Brown Cancer Center· Louisville, KYWashington University· St Louis, MO

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