Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study of Ipatasertib or GDC-0980 With Abiraterone Acetate Versus Coralie in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01485861
First received: December 2, 2011
Last updated: March 20, 2017
Last verified: March 2017

December 2, 2011
March 20, 2017
January 11, 2012
September 1, 2015   (Final data collection date for primary outcome measure)
  • Phase Ib: Percentage of Participants With Dose Limiting Toxicity (DLTs) [ Time Frame: Days 1 to 28 of Cycle 1 (Cycle length = 28 days) ]
  • Phase Ib: Percentage of Participants by Nature of DLTs [ Time Frame: Days 1 to 28 of Cycle 1 (Cycle length = 28 days) ]
  • Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib [ Time Frame: Days 1 to 28 of Cycle 1 (Cycle length = 28 days) ]
  • Phase II: Percentage of Participants With Radiographic Progression (as Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or Death - Intent to Treat (ITT) Population [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Radiographic Progression Free Survival as Assessed by RECIST 1.1 - ITT Population [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With Radiographic Progression (as Assessed by RECIST 1.1) or Death in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Radiographic Progression Free Survival (as Assessed by RECIST 1.1) in Participants With ICR PTEN Loss [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Incidence of dose-limiting toxicity (DLTs) for Phase Ib [ Time Frame: up to 28 days ]
  • Nature of dose-limiting toxicity (DLTs) for Phase Ib [ Time Frame: up to 28 days ]
  • Progression-free survival in all patients and in patients with PTEN loss in Phase II, defined as the time from the first dose of study treatment on Cycle 1 Day 1 to the first observation of disease progression or death from any cause on study [ Time Frame: up to approximately 9 months ]
  • Incidence of adverse events (AEs), graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 9 months ]
  • Nature of adverse events (AEs), graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 9 months ]
  • Severity of adverse events (AEs), graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 9 months ]
Complete list of historical versions of study NCT01485861 on ClinicalTrials.gov Archive Site
  • Phase II: Percentage of Participants Who Died - ITT Population [ Time Frame: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Overall Survival - ITT Population [ Time Frame: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants Who Died in Participants With ICR PTEN Loss [ Time Frame: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Overall Survival in Participants With ICR PTEN Loss [ Time Frame: Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With Prostate-Specific Antigen (PSA) Progression (as Assessed by Prostate Cancer Working Group 2 Criteria) - ITT Population [ Time Frame: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Time to PSA Progression (as Assessed by Prostate Cancer Working Group 2 Criteria) - ITT Population [ Time Frame: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With PSA Progression (as Assessed by Prostate Cancer Working Group 2 Criteria) in Participants With ICR PTEN Loss [ Time Frame: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Time to PSA Progression (as Assessed by Prostate Cancer Working Group 2 Criteria) in Participants With ICR PTEN Loss [ Time Frame: Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With PSA Response - ITT Population [ Time Frame: Baseline, Day 1 of every cycle (starting from Cycle 2) till 30 days after last dose (up to overall 3.6 years) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss [ Time Frame: Baseline, Day 1 of every cycle (starting from Cycle 2) till 30 days after last dose (up to overall 3.6 years) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With Objective Response as Assessed by RECIST 1.1 - ITT Population [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With Objective Response (as Assessed by RECIST 1.1) in Participants With ICR PTEN Loss [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Duration of Tumor Response, as Assessed by RECIST 1.1 - ITT Population [ Time Frame: Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days) ]
  • Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response - ITT Population [ Time Frame: Screening, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days) ]
  • Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss [ Time Frame: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days) ]
  • Phase II: Percentage of Participants With CTC Conversion - ITT Population [ Time Frame: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days) ]
  • Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss [ Time Frame: Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days) ]
  • Phase II: Percentage of Participants With Pain Progression - ITT Population [ Time Frame: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years) ]
  • Phase II: Time to Pain Progression - ITT Population [ Time Frame: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years) ]
  • Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss [ Time Frame: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years) ]
  • Phase II: Time to Pain Progression in Participants With ICR PTEN Loss [ Time Frame: Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years) ]
  • Phase Ib: Maximum Plasma Concentration (Cmax) (in nanograms per milliliter [ng/mL]) of Ipatasertib and GDC-0980 When Co-Administered With Abiraterone [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Time to Cmax (tmax) (in hours) of Ipatasertib and GDC-0980 When Co-Administered With Abiraterone [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Area Under The Concentration Time Curve From Time 0 to 24 Hours (AUC0-24) (in ng/mL*hours) of Ipatasertib and GDC-0980 When Co-Administered With Abiraterone [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Day 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Cmax of G-037720 (Metabolite of Ipatasertib) [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • tmax of G-037720 (Metabolite of Ipatasertib) [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib) [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib) [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or GDC-0980 [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: tmax of Abiraterone When Co-Administered With Ipatasertib or GDC-0980 [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or GDC-0980 [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or GDC-0980 [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or GDC-0980 [ Time Frame: Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days) ]
  • Pharmacokinetics: total exposure (AUC) from Time 0 to the last measurable concentration (AUC0-last) [ Time Frame: Days 1 and 15 of Cycle 1, and on Day 1 of subsequent cycles ]
  • Overall survival defined as the time from randomization until death from any cause [ Time Frame: up to approximately 24 months ]
  • PSA response, defined as a > 50% decrease in PSA from baseline, which is confirmed after >/= 4 weeks by a confirmatory PSA measurement [ Time Frame: up to approximately 9 months ]
  • Confirmed objective tumor response in patients with measurable soft tissue disease at baseline,\nas assessed by the investigator per modified RECIST v1.1 [ Time Frame: up to approximately 9 months ]
  • Duration of objective response in Phase II, defined as the time from first observation of an objective confirmed tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST v1.1 [ Time Frame: up to approximately 9 months ]
Not Provided
Not Provided
 
Study of Ipatasertib or GDC-0980 With Abiraterone Acetate Versus Coralie in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
A Phase Ib/II Study of GDC-0068 or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
This multicenter, international, Phase Ib/II trial consists of two stages: a Phase Ib, open-label stage in which the recommended Phase II dose will be determined for ipatasertib and GDC-0980 in combination with abiraterone and prednisone/prednisolone and a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Abiraterone
    Orally once daily
  • Drug: GDC-0980
    Orally once daily
  • Drug: Ipatasertib
    Orally once daily
  • Drug: Placebo
    Orally once daily
  • Drug: Prednisone
    Orally bid
  • Drug: Prednisolone
    Orally bid
  • Experimental: Phase Ib: Ipatasertib 400 mg + abiraterone
    Participants will receive ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
    Interventions:
    • Drug: Abiraterone
    • Drug: Ipatasertib
    • Drug: Prednisone
    • Drug: Prednisolone
  • Experimental: Phase Ib: GDC-0980 30 mg + abiraterone
    Participants will receive GDC-0980 30 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
    Interventions:
    • Drug: Abiraterone
    • Drug: GDC-0980
    • Drug: Prednisone
    • Drug: Prednisolone
  • Experimental: Phase II: Ipatasertib 400 mg + abiraterone
    Participants will receive Ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
    Interventions:
    • Drug: Abiraterone
    • Drug: Ipatasertib
    • Drug: Prednisone
    • Drug: Prednisolone
  • Experimental: Phase II: Ipatasertib 200 mg + abiraterone
    Participants will receive Ipatasertib 200 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
    Interventions:
    • Drug: Abiraterone
    • Drug: Ipatasertib
    • Drug: Prednisone
    • Drug: Prednisolone
  • Placebo Comparator: Phase II: Placebo + abiraterone
    Participants will receive placebo (for Ipatasertib) once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
    Interventions:
    • Drug: Abiraterone
    • Drug: Placebo
    • Drug: Prednisone
    • Drug: Prednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
273
June 30, 2017
September 1, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel and has progressed during treatment of at least one hormonal therapy
  • Two rising PSA levels greater than or equal to (>/=) 2 ng/mL measured >/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
  • Adequate hematologic and organ function
  • Documented willingness to use an effective means of contraception

Exclusion Criteria:

  • History of Type I or Type II diabetes mellitus requiring insulin
  • New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction < 50% or ventricular arrhythmia requiring medication
  • Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
  • Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
  • Clinically significant history of liver disease
  • History of adrenal insufficiency or hyperaldosteronism
  • Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
  • Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
  • Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   France,   Greece,   Italy,   Netherlands,   Romania,   Spain,   United Kingdom
Australia
 
NCT01485861
GO27983
2011-004126-10 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP