BKM120+Abiraterone Acetate for Metastatic CRPC

NCT01741753 | Terminated Phase 1 DMC

• 1 other identifier: 12-121
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and taht research doctors are trying to find out more about it. It also means that the FDA has not approved the drug for use in patients, including people with your type of cancer. BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to better outcomes in many types of cancer. Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone acetate, individuals must also take a glucocorticoid such as prednisone. Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel, after which treatment with the combination of abiraterone and prednisone has been shown to be effective. Evidence has shown an interaction between the pathways through which BKM120 and abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The purpose of this study is to determine a safe dose for the combination of daily oral BKM120, abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate cancer who have received prior treatment with docetaxel.

Conditions

Prostate Cancer

Keywords

Docetaxel Pretreated; Castrate Resistant; Metastatic

Outcome Measures

Primary Outcomes (1)

• Safety Profile and MTD for BKM120/Abiraterone/Prednisone

  Determine the safety profile and MTD for the combination of BKM120 and abiraterone plus prednisone

  2 years

Secondary Outcomes (2)

• Duration of Response in Expansion Cohort

  2 years

• Impact of PTEN Status on Response Rate/Duration

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

BKM120+Abiraterone+Prednisone

Drug: BKM120; Drug: Abiraterone; Drug: Prednisone

Interventions

BKM120 DRUG

Orally, every morning

Treatment Arm

Abiraterone DRUG

Orally, 1000 mg, every morning

Treatment Arm

Prednisone DRUG

Orally, 5 mg, every morning

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed CRPC with metastatic bone disease
• Castrate resistant disease
• Life expectancy of at least 6 months
• At least four weeks from previous treatment
• At least four weeks since any major surgery or radiation therapy
• Using highly effective contraception

You may not qualify if:

• Thromboembolism within past 6 months
• History of diabetes
• Prior therapy with abiraterone
• Prior therapy with PI3K inhibitor
• Alcohol or drug dependence currently or within past 6 months
• Contraindications to biopsy, such as bleeding disorders
• On anticoagulants such as warfarin or heparin
• Active malignancy other than skin cancer or superficial bladder cancer
• Untreated brain metastases
• Acute or chronic liver, renal disease or pancreatitis
• Mood disorders judged by the investigator to interfere with study participation
• Active cardiac disease or history of cardiac dysfunction
• Uncontrolled hypertension
• Known HIV, Hepatitis B or C
• Serious non-healing wound, ulcer or bone fracture

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Links

• Beth Israel Deaconess Medical Center Cancer Clinical Trials Office.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

NVP-BKM120; abiraterone; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Glenn Bubley, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: November 1, 2012
• Primary Completion: December 29, 2014
• Study Completion: September 1, 2016
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

US (2)