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 September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01485861
First received: December 2, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: GDC-0068
Drug: GDC-0980
Drug: placebo
Drug: abiraterone
Drug: prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 262
Study Start Date: December 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I: Arm A Drug: GDC-0068
Repeating oral dose
Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Experimental: Phase I: Arm B Drug: GDC-0980
Repeating oral dose
Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Experimental: Phase II: Arm A Drug: GDC-0068
400 mg once daily
Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Experimental: Phase II: Arm B Drug: GDC-0068
200 mg once daily
Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Placebo Comparator: Phase II: Arm C Drug: placebo
Repeating oral dose
Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485861

Contacts
Contact: Reference Study ID Number: GO27983 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 63 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01485861     History of Changes
Other Study ID Numbers: GO27983, 2011-004126-10
Study First Received: December 2, 2011
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014