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 — DRUG
    IV over 90 minutes on day 1 of each cycle (every 2 weeks) at the cohort assigned dose level
  • BKM120 — DRUG
    BKM120, 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 + BKM120
    Irinotecan + BKM120 at the assigned cohort dose level.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160-

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