Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

Description

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-resistant prostate cancer (mCRPC).

Study Start Date

June, 30 2017

Estimated Completion Date

August 2023

Interventions

  • Drug: Ipatasertib
  • Drug: Placebo
  • Drug: Abiraterone

Study ID

Hoffmann-La Roche -- CO39303

Status

Recruiting

Trial ID

NCT03072238

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

850

Sponsor

Hoffmann-La Roche

Inclusion Criteria

  • Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 at screening
  • Adequate hematologic and organ function within 28 days before the first study treatment
  • Ability to comply with the study protocol, in the investigator's judgment
  • Willingness and ability of participants (or observers, caregivers) to use the electronic device to report selected study outcomes
  • Life expectancy of at least 6 months
  • Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
  • For enrollment into the China extension cohort, residence in the People's Republic of China Disease-specific

    Inclusion Criteria

    • Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
    • Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases that is subject to decalcification is not acceptable.
    • A valid PTEN IHC result (per central testing) (e.g., participants with an "invalid" or "failed" PTEN IHC result are not permitted to enroll)
    • Metastatic disease documented prior to randomization by bone lesions on bone scan or soft tissue disease by computed tomography (CT) or magnetic resonance imaging (MRI)
    • Asymptomatic or mildly symptomatic form of prostate cancer
    • Progressive disease before initiating study treatment
    • Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or bilateral orchiectomy, with serum testosterone < 50 ng/dL (< 2.0 nmol/L) within 28 days before randomization

    Exclusion Criteria

    • Inability or unwillingness to swallow whole pills
    • History of malabsorption syndrome or other condition that would interfere with enteral absorption
    • Clinically significant history of liver disease consistent 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 corticosteroid therapy (> 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteroids)
    • Active infection requiring intravenous (IV) antibiotics within 14 days before Day 1, Cycle 1
    • Immunocompromised status because of current known active infection with HIV or because of the use of immunosuppressive therapies for other conditions
    • Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of the need for major surgery during study treatment
    • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), myocardial infarction or atrial thrombotic events within the past 6 months, severe unstable angina, New York Heart Association Class III and IV heart disease or depressed left ventricular ejection fraction (LVEF
    • < 50%), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
    • Current treatment with medications that are well known to prolong the QT interval
    • History of other malignancy within the previous 5 years, except for appropriately treated non-melanoma skin carcinoma, or participants who have undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to be at low risk for recurrence
    • Any other diseases, cardiovascular, pulmonary, or metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participants at high risk from treatment complications. Disease-Specific

    Exclusion Criteria

    • Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
    • Treatment with chemotherapy for the treatment of castration-resistant prostate cancer
    • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or any time within 4 weeks of Day 1, Cycle 1
    • Any prior anti-cancer therapy
    • Known untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsant medications or corticosteroids for symptomatic control)
    • a CT or MRI scan of the brain will be performed at screening if required by the local health authority
    • Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or sensitive CYP2D6 substrates with a narrow therapeutic window Abiraterone-Specific

    Exclusion Criteria

    • Uncontrolled hypertension (systolic blood pressure ? 160 mmHg or diastolic blood pressure ? 95 mmHg)
    • History of pituitary or adrenal dysfunction
    • Atrial fibrillation or other cardiac arrhythmia requiring therapy Ipatasertib-Specific

    Exclusion Criteria

    • Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
    • History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (161)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
Rhode Island Hospital - Providence, Rhode Island 41.0 miles None None None
University of Connecticut Health Center - Farmington, Connecticut 100.1 miles None None None
University of Connecticut Health Center - Farmington, Connecticut 100.1 miles None None None
University of Connecticut Health Center - Farmington, Connecticut 100.1 miles None None None
University of Connecticut Health Center - Farmington, Connecticut 100.1 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
Yale Cancer Center - New Haven, Connecticut 119.2 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
New York Oncology Hematology PC - Albany, New York 139.4 miles None None None
Columbia University Medical Center - New York, New York 181.2 miles None None None
Hackensack Univ Medical Center John Theurer Cancer Ctr - Hackensack, New Jersey 183.7 miles None None None
Hackensack Univ Medical Center John Theurer Cancer Ctr - Hackensack, New Jersey 183.7 miles None None None
Hackensack Univ Medical Center John Theurer Cancer Ctr - Hackensack, New Jersey 183.7 miles None None None
Hackensack Univ Medical Center John Theurer Cancer Ctr - Hackensack, New Jersey 183.7 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
Andrews and Patel Associates HematologyOncology - Camp Hill, Pennsylvania 336.7 miles None None None
Andrews and Patel Associates HematologyOncology - Camp Hill, Pennsylvania 336.7 miles None None None
Andrews and Patel Associates HematologyOncology - Camp Hill, Pennsylvania 336.7 miles None None None
Andrews and Patel Associates HematologyOncology - Camp Hill, Pennsylvania 336.7 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Associates in OncologyHematology PC - Rockville, Maryland 391.1 miles None None None
Georgetown University Medical Center - Washington, D.C., District of Columbia 394.4 miles None None None
Georgetown University Medical Center - Washington, D.C., District of Columbia 394.4 miles None None None
Georgetown University Medical Center - Washington, D.C., District of Columbia 394.4 miles None None None
Georgetown University Medical Center - Washington, D.C., District of Columbia 394.4 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
Virginia Oncology Associates - Norfolk, Virginia 468.9 miles None None None
UPMC Cancer Pavillion Hillman Cancer Pavillion - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Cancer Pavillion Hillman Cancer Pavillion - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Cancer Pavillion Hillman Cancer Pavillion - Pittsburgh, Pennsylvania 477.2 miles None None None
UPMC Cancer Pavillion Hillman Cancer Pavillion - Pittsburgh, Pennsylvania 477.2 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Allegheny Cancer Center - Pittsburgh, Pennsylvania 480.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles None None None
University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan 645.2 miles None None None
University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan 645.2 miles None None None
Good Samaritan North Health Center - Dayton, Ohio 709.0 miles None None None
Good Samaritan North Health Center - Dayton, Ohio 709.0 miles None None None
Good Samaritan North Health Center - Dayton, Ohio 709.0 miles None None None
Good Samaritan North Health Center - Dayton, Ohio 709.0 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Carolina Urologic Research Center - Myrtle Beach, South Carolina 728.2 miles None None None
Charleston Hematology Oncology - Charleston, South Carolina 822.7 miles None None None
Charleston Hematology Oncology - Charleston, South Carolina 822.7 miles None None None
Charleston Hematology Oncology - Charleston, South Carolina 822.7 miles None None None
Charleston Hematology Oncology - Charleston, South Carolina 822.7 miles None None None
Northwest Medical Specialists - Arlington Heights, Illinois 864.8 miles None None None
Northwest Medical Specialists - Arlington Heights, Illinois 864.8 miles None None None
Northwest Medical Specialists - Arlington Heights, Illinois 864.8 miles None None None
Northside Hospital - Atlanta, Georgia 929.9 miles None None None
Northside Hospital - Atlanta, Georgia 929.9 miles None None None
Illinois Cancer Care - Peoria, Illinois 964.3 miles None None None
Illinois Cancer Care - Peoria, Illinois 964.3 miles None None None
Illinois Cancer Care - Peoria, Illinois 964.3 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
Lynn Cancer InstituteBoca Raton Regional Hospital - Boca Raton, Florida 1,221.8 miles None None None
HCA Midwest Division - Kansas City, Missouri 1,249.4 miles None None None
HCA Midwest Division - Kansas City, Missouri 1,249.4 miles None None None
HCA Midwest Division - Kansas City, Missouri 1,249.4 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Baptist Health Medical Group Oncology LLC - Miami, Florida 1,271.8 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Urology Cancer Center GU Research Network - Omaha, Nebraska 1,292.2 miles None None None
Simmons Cancer Center Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Simmons Cancer Center Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Simmons Cancer Center Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Simmons Cancer Center Fort Worth - Fort Worth, Texas 1,578.4 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
Texas Oncology Memorial City - Houston, Texas 1,612.5 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles None None None
Ironwood Cancer Research Centers - Chandler, Arizona 2,292.9 miles None None None
Ironwood Cancer Research Centers - Chandler, Arizona 2,292.9 miles None None None
Ironwood Cancer Research Centers - Chandler, Arizona 2,292.9 miles None None None
Ironwood Cancer Research Centers - Chandler, Arizona 2,292.9 miles None None None
Mayo Clinic Arizona - Scottsdale, Arizona 2,298.7 miles None None None
Comprehensive Cancer Centers of Nevada CCCN Central Valley - Las Vegas, Nevada 2,372.5 miles None None None
Comprehensive Cancer Centers of Nevada CCCN Central Valley - Las Vegas, Nevada 2,372.5 miles None None None
Comprehensive Cancer Centers of Nevada CCCN Central Valley - Las Vegas, Nevada 2,372.5 miles None None None
Comprehensive Cancer Centers of Nevada CCCN Central Valley - Las Vegas, Nevada 2,372.5 miles None None None
Madigan Army Medical Center - Tacoma, Washington 2,507.4 miles None None None
Madigan Army Medical Center - Tacoma, Washington 2,507.4 miles None None None
Madigan Army Medical Center - Tacoma, Washington 2,507.4 miles None None None
Northwest Cancer Specialists PC - Tualatin, Oregon 2,544.1 miles None None None
Northwest Cancer Specialists PC - Tualatin, Oregon 2,544.1 miles None None None
Northwest Cancer Specialists PC - Tualatin, Oregon 2,544.1 miles None None None
Northwest Cancer Specialists PC - Tualatin, Oregon 2,544.1 miles None None None
City of Hope - Duarte, California 2,578.2 miles None None None
UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles None None None
UCSD Moores Cancer Center - La Jolla, California 2,581.5 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
UC Irvine Medical Center - Orange, California 2,585.0 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
USCWestside Cancer Ctr - Los Angeles, California 2,593.7 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
USCWestside Cancer Ctr - Los Angeles, California 2,593.7 miles None None None
USCWestside Cancer Ctr - Los Angeles, California 2,593.7 miles None None None
USC Norris Cancer Center - Los Angeles, California 2,593.7 miles None None None
USCWestside Cancer Ctr - Los Angeles, California 2,593.7 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Kaiser Permanente San Diego Los Angeles - Los Angeles, California 2,595.3 miles None None None
Stanford University - Palo Alto, California 2,694.5 miles None None None
Stanford University - Palo Alto, California 2,694.5 miles None None None
Stanford University - Palo Alto, California 2,694.5 miles None None None
Stanford University - Palo Alto, California 2,694.5 miles None None None
Pacific Hematology Oncology Assocociates - San Francisco, California 2,698.0 miles None None None
Pacific Hematology Oncology Assocociates - San Francisco, California 2,698.0 miles None None None
Pacific Hematology Oncology Assocociates - San Francisco, California 2,698.0 miles None None None
Pacific Hematology Oncology Assocociates - San Francisco, California 2,698.0 miles None None None

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