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

Completed · Phase 1

Conditions studied: Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01634061

Run by

Novartis Pharmaceuticals

People needed

43

Starts

2012-09-01

Expected to finish

2015-07-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Cedars Sinai Medical Center SC — Los Angeles, California, United States
• Hackensack University Medical Center Hackensack Univ — Hackensack, New Jersey, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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