Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Abiraterone Acetate; Dactolisib

Criteria

Inclusion Criteria:

• Adult males ≥ 18 years old

• Eastern Cooperative Oncology Group Performance Status ≤ 2

• Patient must have a castrate level of testosterone (<= 50 ng/dL or 1.7 nmol/L). ( Castrate status must be maintained by continued GnRH analogues unless patient has undergone surgical orchiectomy).

• Histologically or cytologically confirmed diagnosis of advanced or metastatic prostate cancer.

• Advanced or metastatic castration-resistant prostate cancer progression after abiraterone acetate failure

• Patients should have no more than 2 lines of prior chemotherapies including cytotoxic agents

• Discontinuation of all anti-androgen, anti-neoplastic or investigational treatment >= 4 weeks (6 weeks for bicalutamide).

Exclusion Criteria:

• Previous treatment with PI3K pathway inhibitors (e.g. PI3K, AKT, mTOR inhibitor), ketoconazole, CYP17 inhibitors (exception of AA), or enzalutamide.

• Patient has active uncontrolled or symptomatic CNS metastases

• Inadequately controlled hypertension (e.g. systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)

• Patient has a QTcF > 480 msec on the screening ECG (using the QTcF formula), has a short/long QT syndrome, or history of QT prolongation/Torsades de Pointes

• Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs

• Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)

• Patients who experienced dose reductions and/or treatment interruptions due to abiraterone acetate related toxicities (i.e. serious AEs, AEs, liver toxicities during abiraterone acetate treatment