Prostate Cancer Clinical Trial

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

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.

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Full Description

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 failure.

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.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT01634061

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 10 Locations for this study

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Cedars Sinai Medical Center SC
Los Angeles California, 90048, United States
Hackensack University Medical Center Hackensack Univ
Hackensack New Jersey, 07601, United States
Novartis Investigative Site
Brussels , BE-B-, Belgium
Novartis Investigative Site
Wilrijk , 2610, Belgium
Novartis Investigative Site
Vancouver British Columbia, V5Z 4, Canada
Novartis Investigative Site
Marseille , 13273, France
Novartis Investigative Site
Villejuif Cedex , 94805, France
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

43

Study ID:

NCT01634061

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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