Status:
WITHDRAWN
BKM120 in Cancers With PIK3CA Activating Mutations
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Lung Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In people whos cancers have a PIK3CA mutation, this trial will be evaluating the drug BKM120 as a possible treatment. BKM120 works by blocking the phosphatidylinositol-3-kinase (PI3K)pathway, thereby ...
Detailed Description
Subjects enrolled in this study will receive BKM120 once daily, orally, in cycles of 28 days. During Cycles 1 and 2, the following tests and procedures will be done on days 1 and 15: * physical exam...
Eligibility Criteria
Inclusion
- At least 1 site of measurable disease
- Life expectancy \>/= 12 weeks
- Adequate marrow and organ function
- Diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer
- Pathologically documented, definitively diagnosed, advanced solid tuor that is refractory to standard treatment, for which no standard therapy is available, or the subject refuses standard therapy
- Cancer must have at least one of the following PIK3CA mutations: E542K, E545K, H1047R, H1047L. The PIK3CA mutation must be documented in a CLIA approved laboratory
Exclusion
- Prior treatment with a P13K inhibitor
- Known hypersensitivity to BKM120 or its excipients
- Untreated brain metastases
- Acute or chronic liver, renal disease or pancreatitis
- Currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A
- Diarrhea \>/= CTCAE grade 2
- Any concurrent severe and/or uncontrolled medical condition
- Active cardiac disease
- History of cardiac dysfunction
- Poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
- Significant symptomatic deterioration of lung function
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKDM120 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant
- Pregnant or breast-feeding
- Known diagnosis of HIV infection
- History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix
- Unable to swallow the medication in its prescribed form
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01501604
Start Date
January 1 2012
End Date
August 1 2013
Last Update
September 17 2015
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