BKM120 in Cancers With PIK3CA Activating Mutations

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Brief Title

BKM120 in Cancers With PIK3CA Activating Mutations

Official Title

An Open Label, Phase II Trial of BKM120 in Cancers With PIK3CA Activating Mutations

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 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.
    

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

        -  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
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response Rate

Secondary Outcome

 Clinical Benefit Rate

Condition

Lung Cancer

Intervention

BKM120


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

January 2012

Completion Date

August 2013

Primary Completion Date

August 2013

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jeffrey A Engelman, MD, PhD, , 



Administrative Informations


NCT ID

NCT01501604

Organization ID

11-211


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 Novartis Pharmaceuticals

Study Sponsor

Jeffrey A Engelman, MD, PhD, Principal Investigator, Massachusetts General Hospital


Verification Date

September 2015