Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily

BKM120

Andrew Armstrong, MD, ScM

The purpose of this study is to evaluate the effects of the study drug, BKM120. The study drug, BKM120, is an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K). This protein is found in normal cells and in cancer cells, but often in many cancer cells this protein is overactive. Inhibiting the protein may slow the growth of prostate cancer but this has not been tested yet in men with prostate cancer.

This is an open label, single arm phase II study of BKM120 in men with metastatic castration resistant prostate cancer (CRPC) who have progressed on or following completion of docetaxel-based chemotherapy. Prior progression on cabazitaxel, provenge, abiraterone, or enzalutamide (MDV3100) is also permitted. Patients must have baseline evaluations performed prior to the first dose of study drug and must meet all inclusion and exclusion criteria. Results of the baseline evaluations, which assure that all inclusion and exclusion criteria have been satisfied, must be reviewed by the Principal Investigator or his/her designee prior to enrollment of that patient. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to protocol-specific screening tests. The following criteria apply to all patients enrolled onto the study unless otherwise specified.

BKM120 in Metastatic Castration-resistant Prostate Cancer

Phase II Study of BKM120 in Men With Metastatic Castration-Resistant Prostate Cancer

Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.

Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

The number of patients with a 30% and 50% decrease in PSA from baseline.

Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.

The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.

Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.

Novartis Pharmaceuticals

Andrew J. Armstrong, MD

Assoc Professor of Medicine

BKM 120

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Andrew J. Armstrong, MD ScM FACP

Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.

Radiologic Response

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

30% Decrease

50% Decrease

Prostate Specific Antigen (PSA) Response

Overall Survival of Participants.

13 patients had measured CTC levels above 5 at baseline

Change in Circulating Tumor Cell (CTC) Levels From Baseline

Only those patients that experienced a new lesion per this definition are included.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BKM120 in Metastatic Castration-resistant Prostate Cancer	NCT01385293	Prostate Cancer Metastatic (Spr...	BKM120	18 Years -	Duke University
BKM120 in Metastatic Castration-resistant Prostate Cancer	NCT01385293	Prostate Cancer Metastatic (Spr...	BKM120	18 Years -	Duke University

Spots Global Cancer Trial Database for metastatic (spread to other areas of the body)