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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



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