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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01485861
First received: December 2, 2011
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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 GDC-0068 and GDC-0980 in combination with abiraterone and prednisone/prednisolone and a Phase II, 3-arm, double-blind, randomized comparison of GDC-0068 with 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:

U.S. FDA Resources

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 ]
  • 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 ]
  • 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 for 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 ]

Enrollment: 21
Study Start Date: December 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: August 2014 (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
Placebo Comparator: Phase I: Arm C Drug: placebo
Repeating oral dose
Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Experimental: Phase II: Arm A Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Drug: GDC-0068
400 mg once daily
Experimental: Phase II: Arm B Drug: abiraterone
Repeating oral dose
Drug: prednisone
Repeating oral dose
Drug: GDC-0068
200 mg once daily
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, 1, or 2
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485861

  Hide Study Locations
Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
San Francisco, California, United States, 94115
United States, Florida
Sarasota, Florida, United States, 34232
United States, Hawaii
Honolulu, Hawaii, United States, 96819
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Nashville, Tennessee, United States, 37203
Czech Republic
Praha, Czech Republic, 128 08
France
Angers, France, 49933
La Roche Sur Yon, France, 85925
Nantes, France, 44805
Paris, France, 75231
Villejuif, France, 94805
Greece
Athens, Greece, 115 22
Athens, Greece, 11527
Athens, Greece, 145 64
Heraklion, Greece, 71110
Neo Faliro, Greece, 18574
Patras, Greece, 26500
Italy
Cremona, Italy, 26100
Meldola, Italy, 47014
Milano, Italy, 20132
Milano, Italy, 20133
Netherlands
Amsterdam, Netherlands, 1081 HV
Amsterdam, Netherlands, 1066
Blaricum, Netherlands, 1261 AN
Hoofddorp, Netherlands, 2134 TM
Romania
Cluj Napoca, Romania, 400015
Cluj-napoca, Romania, 400015
Timisoara, Romania, 300239
Spain
Barcelona, Spain, 08916
Barcelona, Spain, 08035
Madrid, Spain, 28041
Pamplona, Spain, 31008
Sabadell, Barcelona, Spain, 08208
United Kingdom
Southampton, United Kingdom, SO16 6YD
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: January 10, 2013
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
Prednisone
Docetaxel
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013