NCT01591421

P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer.

Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination With Panitumumab in Patients With Metastatic or Advanced RAS-Wild Type Colorectal Cancer.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For the first phase of this study (phase I), the purpose will be to find the dose of a new drug, BKM120, that can safely be given in combination with standard dose panitumumab. For the second phase of this study (phase II), the purpose is to find out what effects the combination of BKM120 and panitumumab, in doses found to be safe in the first part of the study, has on patients and their colorectal cancer.

Detailed description

This is done by starting with doses of BKM120 at lower than the usual dose. Patients are given BKM120 and panitumumab and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given higher doses of BKM120. If severe toxicity is seen, doses of BKM120 and/or panitumumab doses may be lowered in subsequent patients. Patients joining the study later on will normally get higher doses of BKM120 than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BKM120	PO; Once daily starting day 1 cycle 1, or 5 out of 7 days every week.
DRUG	Panitumumab	IV; Every two weeks starting day 1 cycle 1 (i.e. day 1 and 15 each 28 day cycle)

Timeline

• Start date: 2012-09-06
• Primary completion: 2015-09-30
• Completion: 2019-11-12
• First posted: 2012-05-04
• Last updated: 2023-08-04

Locations

3 sites across 1 country: Canada