A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Genentech, Inc.
Study ID
NCT00671372
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • FOLFIRI regimen — DRUG
    Intravenous repeating dose
  • bevacizumab — DRUG
    Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
  • cetuximab — DRUG
    Intravenous repeating dose
  • dulanermin — DRUG
    Intravenous repeating dose
  • irinotecan — DRUG
    Intravenous repeating dose

Study Details

This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).

Key Dates

Start date
Jul 31, 2006
Status verified
Nov 2016
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohorts 1-5
  • Experimental: Cohorts 6, 6A, 7, 7A

Primary Outcome Measure

The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux [ Time Frame: Length of study ]

Locations (10)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia90095-
-RedlandsCalifornia92374-
-San FranciscoCalifornia94115-
-Fort MyersFlorida33916-
-HarveyIllinois60426-
-BuffaloNew York14263-
-DurhamNorth Carolina27710-
-HersheyPennsylvania17033-
-NashvilleTennessee37203-
-TacomaWashington98405-

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