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 — DRUGIntravenous repeating dose
- bevacizumab — DRUGIntravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
- cetuximab — DRUGIntravenous repeating dose
- dulanermin — DRUGIntravenous repeating dose
- irinotecan — DRUGIntravenous 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Los Angeles | California | 90095 | - |
| - | Redlands | California | 92374 | - |
| - | San Francisco | California | 94115 | - |
| - | Fort Myers | Florida | 33916 | - |
| - | Harvey | Illinois | 60426 | - |
| - | Buffalo | New York | 14263 | - |
| - | Durham | North Carolina | 27710 | - |
| - | Hershey | Pennsylvania | 17033 | - |
| - | Nashville | Tennessee | 37203 | - |
| - | Tacoma | Washington | 98405 | - |
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