A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer
Part of paid clinical trials in Kansas City, Kansas.
- Sponsor
- University of Kansas Medical Center
- Study ID
- NCT01304602
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan — DRUGIV over 90 minutes on day 1 of each cycle (every 2 weeks) at the cohort assigned dose level
- BKM120 — DRUGBKM120, oral, daily starting with cycle 1/day 2 at the cohort defined dose level
Study Details
This phase I trial will use the combination of irinotecan and BKM120 in patients with advanced colorectal cancer who have failed on or have become intolerant of at least one line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.
Key Dates
- Start date
- Feb 28, 2011
- Status verified
- Jan 2017
- Primary completion
- Apr 30, 2014
- Completion
- Oct 31, 2015
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Irinotecan + BKM120Irinotecan + BKM120 at the assigned cohort dose level.
Primary Outcome Measure
Maximum tolerated dose [ Time Frame: 28 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | - |
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