Study of GDC-0068 Or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01485861
First received: December 2, 2011
Last updated: July 7, 2014
Last verified: July 2014

December 2, 2011
July 7, 2014
December 2011
June 2015   (final data collection date for primary outcome measure)
  • Incidence of dose-limiting toxicity (DLTs) for Phase Ib [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Nature of dose-limiting toxicity (DLTs) for Phase Ib [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs), graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
  • Nature of adverse events (AEs), graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
  • Severity of adverse events (AEs), graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
  • Radiographic progression-free survival in all patients and in patients with PTEN loss in Phase II [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01485861 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival for Phase II [ Time Frame: up to approximately 24 months ] [ Designated as safety issue: No ]
  • PSA response, defined as a > 50% decrease in PSA from baseline, which is confirmed after >/= 4 weeks by a confirmatory PSA measurement for Phase II [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
  • Confirmed objective tumor response in patients with measurable soft tissue disease at baseline, as assessed by the investigator per modified RECIST v1.1 for Phase II [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
  • 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 for Phase II [ Time Frame: up to approximately 9 months ] [ Designated as safety issue: No ]
  • Decrease in number of circulating tumor cells for Phase II [ Time Frame: from baseline to up to approximately 9 months ] [ Designated as safety issue: No ]
  • Change in pain symptom score as measured by the modified Brief Pain Inventory-Short Form for Phase II [ Time Frame: from baseline to up to approximately 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall survival defined as the time from randomization until death from any cause [ Time Frame: up to approximately 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of GDC-0068 Or GDC-0980 With Abiraterone Acetate Versus Abiraterone Acetate in Patients 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 Pha se Ib, open-label stage in which the recommended Phase II dose will be determine d for GDC-0068 and GDC-0980 in combination with abiraterone and prednisone/predn isolone and a Phase II, 3-arm, double-blind, randomized comparison of GDC-0068 w ith abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: GDC-0068
    400 mg once daily
  • Drug: GDC-0068
    200 mg once daily
  • Drug: GDC-0068
    Repeating oral dose
  • Drug: GDC-0980
    Repeating oral dose
  • Drug: placebo
    Repeating oral dose
  • Drug: abiraterone
    Repeating oral dose
  • Drug: prednisone
    Repeating oral dose
  • Experimental: Phase I: Arm A
    Interventions:
    • Drug: GDC-0068
    • Drug: abiraterone
    • Drug: prednisone
  • Experimental: Phase I: Arm B
    Interventions:
    • Drug: GDC-0980
    • Drug: abiraterone
    • Drug: prednisone
  • Experimental: Phase II: Arm A
    Interventions:
    • Drug: GDC-0068
    • Drug: abiraterone
    • Drug: prednisone
  • Experimental: Phase II: Arm B
    Interventions:
    • Drug: GDC-0068
    • Drug: abiraterone
    • Drug: prednisone
  • Placebo Comparator: Phase II: Arm C
    Interventions:
    • Drug: placebo
    • Drug: abiraterone
    • Drug: prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
262
November 2015
June 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 >/= 2 ng/mL measured >/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
  • 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
  • NYHA Class III or IV heart failure or LVEF < 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 CYP17 inhibitors, including abiraterone
  • Phase II only: Previous treatment for prostate cancer with Akt, PI3K, and/or mTOR inhibitors
  • Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant
Male
18 Years and older
No
Contact: Reference Study ID Number: GO27983 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Czech Republic,   France,   Greece,   Italy,   Netherlands,   Romania,   Spain,   United Kingdom
 
NCT01485861
GO27983, 2011-004126-10
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
July 2014

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