NCT01304602

A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer

A Phase I Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Although survival of patients with advanced colorectal cancer has improved in the last two decades, the overwhelming majority of these patients will still succumb from this disease. It is the third most commonly diagnosed malignancy in the United States. We have witnessed significant leaps in understanding colorectal cancer carcinogenesis as well as in identification of a number of prognostic and predictive factors associated with this malignancy. With the use of combination chemotherapy and the addition of targeted agents, the median survival of patients with advanced colorectal cancer has improved from 4-6 months with supportive care to over 2 years. Molecularly directed therapy for cancer holds promise to a more personalized approach to treating cancer. Increase understanding of tumorigenesis has resulted in the identification of promising targets of therapy for more strategic approach to treatment of this malignancy. However, even with the development of molecularly directed treatment, the therapy for advanced colorectal cancer remains to be primarily palliative in nature to majority of patients. There is definite need for a more effective therapy, agents with more acceptable toxicity profiles, and drugs that could be administered without significant demand on time and activity for individual patients receiving these drugs. This is a phase I trial of 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. This study will attempt to estimate the Maximum Tolerated Dose of the combination of irinotecan and BKM120.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	IV over 90 minutes on day 1 of each cycle (every 2 weeks) at the cohort assigned dose level
DRUG	BKM120	BKM120, oral, daily starting with cycle 1/day 2 at the cohort defined dose level

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-04-01
• Completion: 2015-10-01
• First posted: 2011-02-25
• Last updated: 2017-01-06

Locations

1 site across 1 country: United States