P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Patients With Metastatic or Advanced RAS-Wild Type Colorectal Cancer.
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|ClinicalTrials.gov Identifier: NCT01591421|
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : November 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: BKM120 Drug: Panitumumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||May 1, 2012|
|Actual Primary Completion Date :||September 30, 2015|
|Actual Study Completion Date :||November 12, 2019|
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.
IV; Every two weeks starting day 1 cycle 1 (i.e. day 1 and 15 each 28 day cycle)
- Recommended phase II dose of BKM120 (Phase I Component) [ Time Frame: 24 months ]Determine the safety, tolerability, toxicity profile and dose limiting toxicities of BKM120 and Panitumumab.
- Anti-tumour activity (Phase II Component) [ Time Frame: 24 months ]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 ]To investigate the correlation, if any, between response and molecular biomarkers in archival FFPE tumour.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|