Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT01116271
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- AZD6244 — DRUG50 or 75mg, capsules, PO, BID, 28 days
- Irinotecan — DRUG180mg/m2, IV, Day 1\& 15 of each cycle
Study Details
The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.
Key Dates
- Start date
- Apr 30, 2010
- Status verified
- Jan 2013
- Primary completion
- Jul 31, 2012
- Completion
- Jul 31, 2012
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1Selumetinib (AZD6244) in combination with irinotecan
Primary Outcome Measure
Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol. [ Time Frame: AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Los Angeles | California | - | - |
| Research Site | Palm Springs | California | - | - |
| Research Site | Aurora | Colorado | - | - |
| Research Site | New Haven | Connecticut | - | - |
| Research Site | Newark | Delaware | - | - |
| Research Site | Miami Beach | Florida | - | - |
| Research Site | New York | New York | - | - |
| Reserach Site | Chapel Hill | North Carolina | - | - |
| Research Site | Greenville | North Carolina | - | - |
| Research Site | Washington | North Carolina | - | - |
| Research Site | Philadelphia | Pennsylvania | - | - |
| Research Site | Seattle | Washington | - | - |
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