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Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Males with Metastatic Castrate-Resistant Prostate Cancer


Title A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients with Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer
Therapeutic Area Prostate Cancer
Principal Investigator Paul Mathew, MD
Min Age 18 Years
Gender Male
Contact Brenda Taveras-Rosa
617-636-8589
More Information https://www.clinicaltrials.gov/ct2/show/NCT03072238

Overview

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistance prostate cancer (mCRPC)

Study Details

Inclusion Criteria

  • Progressive disease before initiating study treatment
  • Histologically confirmed prostate adenocarcinoma without neuroedocrine differentiation or small-cell features
  • Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

  • Clinically significant history of liver disease consistence with Child-Pugh Class B or C, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Need for current chronic corticosteriod therapy (> 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteriods)
  • Treatment with chemotherapy for the treatment of castration-resistance prostate cancer

Study Requirements

Elibable subjects will be assigned by chance (like the flip of a coin) to receive either ipatasertib in combination with abiraterone or placebo in combination with abiraterone. Subjects will have a 50% (1 in 2) chance of receiving ipatasertib in combination with abiraterone, and a 50% (1 in 2) chance of receiving placebo in combination with abiraterone. Each treatment cycle last 4 weeks (i.e 28 days). During each cycle subjects will receive ipatasertib 400mg or placebo in addition to abiraterone and prednisone. 

MRI, CT, and Bone scans are required as part of the screening process (28 day window) and at the end of Cycles 2, 4, 6, 9, 12 and every 3 cycles thereafter. This frequency is considered the standard of care treatment for metastatic prostate cancer. 

The total volume of blood that will be collected during the screening visits is approximately 9 teaspoons (44mL). The total volume of blood that will be collected for study-related analysis will be approximately 93 teaspoons (458mL). This is an estimated amount based on remaining study treatment for 1 year, it will be more or less depending how long you remain in the study.

Subjects will receive study drugs until it has been determined that the cancer has progressed, until the study treatment becomes intolerable, or until the completion or termination of the study.

Besides blood work and imaging, subjects will undergo ECG, physical examinations and will be asked to complete a study diary to record study drug administration and symptoms.