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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: June 9, 2017
Last verified: June 2017
  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 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.

Condition Intervention Phase
Prostate Cancer Drug: Abiraterone Drug: GDC-0980 Drug: Ipatasertib Drug: Placebo Drug: Prednisone Drug: Prednisolone Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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, Inc.:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 273
Actual Study Start Date: January 11, 2012
Estimated Study Completion Date: June 30, 2017
Primary Completion Date: September 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Abiraterone
Orally once daily
Drug: Ipatasertib
Orally once daily
Drug: Prednisone
Orally bid
Drug: Prednisolone
Orally bid
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.
Drug: Abiraterone
Orally once daily
Drug: GDC-0980
Orally once daily
Drug: Prednisone
Orally bid
Drug: Prednisolone
Orally bid
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.
Drug: Abiraterone
Orally once daily
Drug: Ipatasertib
Orally once daily
Drug: Prednisone
Orally bid
Drug: Prednisolone
Orally bid
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.
Drug: Abiraterone
Orally once daily
Drug: Ipatasertib
Orally once daily
Drug: Prednisone
Orally bid
Drug: Prednisolone
Orally bid
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.
Drug: Abiraterone
Orally once daily
Drug: Placebo
Orally once daily
Drug: Prednisone
Orally bid
Drug: Prednisolone
Orally bid

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 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
  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

  Hide Study Locations
Locations
United States, Arizona
HonorHealth Research Institute - Pima Center
Scottsdale, Arizona, United States, 85258
United States, California
Pacific Hematology Oncology Assocociates
San Francisco, California, United States, 94115
United States, Florida
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers, Florida, United States, 33901-8101
Florida Cancer Specialists.
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists; Sarasota
Sarasota, Florida, United States, 34232
United States, Hawaii
Kaiser Permanente Medical Ctr
Honolulu, Hawaii, United States, 96819
United States, Maryland
Johns Hopkins Univ; Bunting Blaustein Cancer Center
Baltimore, Maryland, United States, 21231
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
North Shore Hem Onc Associates
East Setauket, New York, United States, 11733
Weill Cornell Medical College
New York, New York, United States, 10021
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Czechia
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie
Hradec Kralove, Czechia, 50012
Urocentrum Praha s.r.o.
Praha 2, Czechia, 120 00
Vseobecna fakultni nemocnice v Praze
Praha 2, Czechia, 128 08
Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni
Praha, Czechia, 140 59
France
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche Sur Yon, France, 85925
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon, France, 69008
Hia Du Val De Grace
Paris, France, 75230
Institut Curie; Oncologie Medicale
Paris, France, 75231
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris, France, 75674
Hopital d'Instruction des Armees de Begin
Saint-Mande, France, 94160
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, France, 94805
Greece
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens, Greece, 115 28
Sotiria Hospital
Athens, Greece, 11527
General Oncology Hospital Kifissias "Oi Agioi Anargyroi"
Athens, Greece, 145 64
Univ General Hosp Heraklion; Medical Oncology
Heraklion, Greece, 711 10
University Hospital of Larissa; Oncology
Larissa, Greece, 41 110
University Hospital of Patras Medical Oncology
Patras, Greece, 265 04
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, Greece, 185 47
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma, Lazio, Italy, 00152
Azienda Ospedaliera Istituti Ospitalieri
Cremona, Lombardia, Italy, 26100
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
Ospedale S. Donato; Divisione Di Reumatologia
Arezzo, Toscana, Italy, 52100
Netherlands
Het Nederlands Kanker Inst
Amsterdam, Netherlands, 1066 EC
Vu Medisch Centrum; Afdeling Longziekten
Amsterdam, Netherlands, 1081 HV
MC Haaglanden; Oncologie
Den Haag, Netherlands, 2512 VA
UMC St Radboud
Nijmegen, Netherlands, 6525 GA
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Rotterdam, Netherlands, 3045 PM
Romania
Sf. Constantin Hospital; Oncology
Brasov, Romania, 500019
Prof. Dr. Th. Burghele Clin Urology Hosp
Bucharest, Romania, 050659
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Institute of Oncology "Prof. Dr. I. Chiricuta"
Cluj-Napoca, Romania, 400015
ONCOMED - Medical Centre
Timisoara, Romania, 300239
Municipal Hosp Turdal; Oncology
Turda, Romania, 401103
Spain
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, Spain, 03203
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, Spain, 08208
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Spain, 29010
United Kingdom
Queen Elizabeth Hospital; Centre for Clinical Haematology
Birmingham, United Kingdom, B15 2TH
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0XH
St. James University Hospital; Pharmacy Department
Leeds, United Kingdom, LS9 7TF
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral, United Kingdom, L63 4JY
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01485861     History of Changes
Other Study ID Numbers: GO27983
2011-004126-10 ( EudraCT Number )
Study First Received: December 2, 2011
Last Updated: June 9, 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
Prednisolone
Methylprednisolone Hemisuccinate
Abiraterone Acetate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on July 19, 2017