BKM120 in Cancers With PIK3CA Activating Mutations
This study has been terminated.
(The study has been closed due to lack of accrual)
Sponsor:
Massachusetts General Hospital
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Jeffrey Engelman, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01501604
First received: December 27, 2011
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
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 inhibiting tumor growth and survival.
The purpose of this study is to learn if the study drug BKM120 can shrink or slow the growth of your tumor. The safety of BKM120 will also be studied. Your physical state, symptoms, change in the size of your tumor, and laboratory findings obtained while you are on study will help the research team decide if BKM120 is safe and effective in patients with advanced cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Breast Cancer Colorectal Cancer Cholangiocarcinoma Solid Tumors |
Drug: BKM120 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]Objective Response Rate (CR or PR) by RECIST 1.1 criteria
Secondary Outcome Measures:
- Clinical Benefit Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]Clinical Benefit Rate (CR, PR, or SD) by RECIST 1.1 criteria
- Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression Free Survival (PFS)
- Clinical Benefit [ Time Frame: 2 years ] [ Designated as safety issue: No ]Determine if the presence of specific co-existing mutations may influence clinical benefit from BKM120
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: BKM120
100 MG PO QD in cycles of 28 days
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
- performance status
- blood tests
- pregnancy test (if applicable)
- neuropsychiatric assessments
Starting at Cycle 2 and then every other cycle thereafter (approximately every 8 weeks) tumor assessment will be performed by CT/MRI or PET scan. A chest x-ray will also be performed every 8 weeks.
Beginning with Cycle 3, the following tests/procedures will be performed on Day 1 of each cycle:
- physical exam
- performance status
- blood tests
- neuropsychiatric assessments
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Jeffrey Engelman, Director, Thoracic Oncology, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01501604 History of Changes |
| Other Study ID Numbers: | 11-211 |
| Study First Received: | December 27, 2011 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
PIK3CA mutation Advanced solid tumors |
Additional relevant MeSH terms:
|
Breast Neoplasms Colorectal Neoplasms Lung Neoplasms Cholangiocarcinoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 19, 2013