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

NCT01591421 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Derek Jonker · Ottawa Health Research Institute - General Division

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-06
Primary Completion
2015-09-30
Completion
2019-11-12

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01591421 on ClinicalTrials.gov