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Phase Ib Dose Finding Study of Abiraterone Acetate Plus BEZ235 or BKM120 in Patients With Castration-resistant Prostate Cancer.

Phase 1
18 Years
Open (Enrolling)
Castration-resistant Prostate Cancer

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Trial Information

Phase Ib Dose Finding Study of Abiraterone Acetate Plus BEZ235 or BKM120 in Patients With Castration-resistant Prostate Cancer.

A dose-escalation part will first determine the maximum tolerated dose (MTD) and/or
recomended dose for expansion (RDE) of abiraterone acetate in combination with BEZ235 and
abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate

Subsequently, the MTD and/or RDE of each combination will be investigated in two expansion
treatment groups of CRPC patients who have failed abiraterone acetate therapy.

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
castration resistant 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 (i.e. docetaxel)

- 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, AA or other CYP17 inhibitors (exception of AA), or MDV3100.

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities (DLTs)

Outcome Description:

Dose escalation part: Determine MTD and /or RDE of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of DLTs in cycle 1

Outcome Time Frame:

from days 8-35 in BEZ235/abiraterone acetate arm and from days 0-28 in BKM120/abiraterone acetate arm

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

September 2012

Completion Date:

April 2015

Related Keywords:

  • Castration-Resistant Prostate Cancer
  • Castration-resistant prostate cancer, abiraterone acetate, BEZ235, BKM120, dose escalation, abiraterone acetate failure
  • Prostatic Neoplasms



Horizon Oncology Center Horizon Onc Lafayette, Indiana  47905
Cedars Sinai Medical Center SC Los Angeles, California  90048
Hackensack University Medical Center Hackensack Univ Hackensack, New Jersey  07601
H. Lee Moffitt Cancer Center/University of South Florida Dept of Onc Tampa, Florida  33612
University of Michigan Comprehensive Cancer Center Dept of Oncology Ann Arbor, Michigan  48109-0944
NYU Langone Medical Center Clinical Cancer Center New York, New York  10016
Memorial Hermann/Memorial City Hospital University of Texas Houston, Texas  77024