P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Patients With Metastatic or Advanced RAS-Wild Type Colorectal Cancer.
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.
Metastatic Colorectal Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Recommended phase II dose of BKM120 (Phase I Component) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Determine the safety, tolerability, toxicity profile and dose limiting toxicities of BKM120 and Panitumumab.
- Anti-tumour activity (Phase II Component) [ Time Frame: 24 months ] [ Designated as safety issue: No ]To assess the anti-tumour activity of BKM120 in combination with panitumumab as evidenced by response rates and early progression rates in patients with K-RAS wild-type metastatic colorectal cancer.
- Translational Research [ Time Frame: 24 months ] [ Designated as safety issue: No ]To investigate the correlation, if any, between response and molecular biomarkers in archival FFPE tumour.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: BKM120 and Panitumumab
BKM120 will be given either daily starting day 1 cycle 1or 5 out of 7 days every week, depending on when patient is enrolled on the study, in combination with panitumumab given intravenously every two weeks starting day 1 cycle 1.
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591421
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada, K1H 8L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Derek Jonker||Ottawa Health Research Institute - General Division|