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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01485861
• Collaborator: (none)
• Enrollment: 273
• Locations: 59
• Arms: 6
• Anticipated Duration (Months): 127.6
• Patients Per Site: 4.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Abiraterone; Drug: Apitolisib; Drug: Ipatasertib; Drug: Placebo; Drug: Prednisone; Drug: Prednisolone	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 273 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: In Phase II participants and investigators were blinded with regard to treatment status (i.e., ipatasertib vs. placebo). Phase Ib and the safety cohort were open-label.
• Primary Purpose: Treatment
• Official Title: A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
• Actual Study Start Date: Jan 11, 2012
• Actual Primary Completion Date: Sep 1, 2015
• Anticipated Study Completion Date: Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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: Apitolisib 30 mg + abiraterone Participants will receive apitolisib 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: Apitolisib; 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
Experimental: Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone Participants will receive Ipataseritib 400 mg once daily in the AM for Cycle 1 day 1-18. On Day 19, Ipataseritib 400 mg will be switched to PM dosing for the remainder of the Cycle 1. Prednisone 5 mg starts in the PM of Cycle 1 day 8 and taken BID thereafter for the remainder of the study treatment Abiraterone 1000mg once a day starts on Cycle1 day 12 in the AM and should be taken at the same time as Ipataseritib. Starting from cycle 1 day 19, Ipataseritib and Abiraterone are dosed in PM at should be taken together at the same time each day until cycle 2 day 1. Starting from Cycle 2 Day 1, Participants may choose to take Ipatasertib and Abiraterone in either the AM or PM; however, they should be taken together at approximately the same time each day. Participants will receive the study treatment until disease progression or intolerable toxicity.	Drug: Abiraterone; Orally once daily; Drug: Ipatasertib; Orally once daily; Drug: Prednisone; Orally bid; Drug: Prednisolone; Orally bid

Outcome Measures

Primary Outcome Measures

1. Phase Ib: Percentage of Participants With Dose Limiting Toxicity (DLTs) [Days 1 to 28 of Cycle 1 (Cycle length = 28 days)]

2. Phase Ib: Percentage of Participants with Adverse Events (AEs) [Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to 3.6 years overall)]

3. Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib [Days 1 to 28 of Cycle 1 (Cycle length = 28 days)]

4. Phase II: Radiographic Progression Free Survival (rPFS) - Intent-To-Treat (ITT) Population [Screening up to radiographic progression or death, whichever occurs first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter, and at treatment completion [up to 3.6 years overall]) (cycle length = 28 days)]

5. Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss [Screening up to radiographic progression or death, whichever occurs first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter, and at treatment completion [up to 3.6 years overall]) (cycle length = 28 days)]

Secondary Outcome Measures

1. Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

2. Phase Ib: Time to Cmax (tmax) of Ipatasertib When Co-Administered With Abiraterone [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

3. Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

4. Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

5. Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

6. Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib) [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

7. Phase Ib: tmax of G-037720 (Metabolite of Ipatasertib) [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

8. Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib) [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Day 15 of Cycle 1 (cycle length=28 days)]

9. Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib) [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

10. Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone [Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)]

11. Phase Ib: tmax of Apitolisib When Co-Administered With Abiraterone [Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)]

12. Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone [Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)]

13. Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

14. Phase Ib: tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

15. Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

16. Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

17. Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib [Predose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length=28 days)]

18. Phase II: Overall Survival in the ITT Population [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 8.9 years overall]) (cycle length = 28 days)]

19. Phase II: Overall Survival in Participants With ICR PTEN Loss [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 8.9 years overall]) (cycle length = 28 days)]

20. Phase II: Percentage of Participants With PSA Progression in the ITT Population [Baseline up to 30 days after last dose (assessed at 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)]

21. Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss [Baseline up to 30 days after last dose (assessed at 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)]

22. Phase II: Time to PSA Progression in the ITT Population [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)]

23. Phase II: Time to PSA Progression in Participants With ICR PTEN Loss [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)]

24. Phase II: Percentage of Participants With PSA Response in the ITT Population [Baseline up to 30 days after last dose (assessed at 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)]

25. Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss [Baseline up to 30 days after last dose (assessed at 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)]

26. Phase II: Percentage of Participants With Objective Response in the ITT Population [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)]

27. Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss [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)]

28. Phase II: Duration of Tumor Response in the ITT Population [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)]

29. Phase II: Duration of Tumor Response in Participants with ICR PTEN Loss [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)]

30. Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response in the ITT Population [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)]

31. Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss [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)]

32. Phase II: Percentage of Participants With CTC Conversion in the ITT Population [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)]

33. Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss [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)]

34. Phase II: Percentage of Participants With Pain Progression in the ITT Population [Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)]

35. Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss [Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)]

36. Phase II: Time to Pain Progression in the ITT Population [Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)]

37. Phase II: Time to Pain Progression in Participants With ICR PTEN Loss [Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)]

38. Phase II: Percentage of Participants With Adverse Events (AEs) [Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to 8.9 years)]

39. Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone [Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)]

40. Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations [Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length=28 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)

• 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

• Safety cohort only: agreement to use CGM for first cycle of treatment

Exclusion Criteria:

• History of Type I or Type II diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible

• 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

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute - Bisgrove	Scottsdale	Arizona	United States	85258
2	Pacific Hematology Oncology Associates	San Francisco	California	United States	94115
3	Florida Cancer Specialists - Fort Myers (New Hampshire Ct)	Fort Myers	Florida	United States	33901-8101
4	Florida Cancer Specialists; Sarasota	Sarasota	Florida	United States	34232
5	Kaiser Permanente Medical Ctr	Honolulu	Hawaii	United States	96819
6	Johns Hopkins Univ; Bunting Blaustein Cancer Center	Baltimore	Maryland	United States	21231
7	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
8	Urology Cancer Center & GU Research Network	Omaha	Nebraska	United States	68130
9	New York Cancer and Blood Specialists - Setauket Medical Oncology	East Setauket	New York	United States	11733
10	Weill Cornell Medical College	New York	New York	United States	10065
11	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
12	Sarah Cannon Cancer Center - Tennessee Oncology, Pllc	Nashville	Tennessee	United States	37203
13	Masarykuv onkologicky ustav	Brno		Czechia	656 53
14	Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie	Hradec Kralove		Czechia	50012
15	Urocentrum Praha s.r.o.	Praha 2		Czechia	120 00
16	Vseobecna fakultni nemocnice v Praze	Praha 2		Czechia	128 08
17	Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni	Praha		Czechia	140 59
18	ICO Paul Papin; Oncologie Medicale.	Angers		France	49055
19	Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes	Lyon		France	69008
20	Hia Du Val De Grace	Paris		France	75230
21	Institut Curie; Oncologie Medicale	Paris		France	75231
22	GH Paris Saint Joseph; Hopital De Jour Oncologie	Paris		France	75674
23	Hopital d'Instruction des Armees de Begin	Saint-Mande		France	94160
24	Institut Gustave Roussy; Departement Oncologie Medicale	Villejuif		France	94805
25	Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine	Athens		Greece	115 28
26	Univ General Hosp Heraklion; Medical Oncology	Heraklion		Greece	711 10
27	University Hospital of Patras Medical Oncology	Patras		Greece	265 04
28	Metropolitan Hospital; 2Nd Oncology Clinic	Piraeus		Greece	185 47
29	University Hospital of Larissa; Oncology	Λαρισα		Greece	413 35
30	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna	Italy	47014
31	Azienda Ospedaliera Istituti Ospitalieri	Cremona	Lombardia	Italy	26100
32	Irccs Ospedale San Raffaele;Oncologia Medica	Milano	Lombardia	Italy	20132
33	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2	Milano	Lombardia	Italy	20133
34	Ospedale S. Donato; Divisione Di Reumatologia	Arezzo	Toscana	Italy	52100
35	Het Nederlands Kanker Inst	Amsterdam		Netherlands	1066 EC
36	Vu Medisch Centrum; Afdeling Longziekten	Amsterdam		Netherlands	1081 HV
37	MC Haaglanden; Oncologie	Den Haag		Netherlands	2512 VA
38	UMC St Radboud	Nijmegen		Netherlands	6525 GA
39	Sint Franciscus Gasthuis; Inwendige Geneeskunde	Rotterdam		Netherlands	3045 PM
40	Sf. Constantin Hospital; Oncology	Brasov		Romania	500019
41	Prof. Dr. Th. Burghele Clin Urology Hosp	Bucharest		Romania	050659
42	Prof. Dr. I. Chiricuta Institute of Oncology	Cluj Napoca		Romania	400015
43	ONCOMED - Medical Centre	Timisoara		Romania	300239
44	Municipal Hosp Turdal; Oncology	Turda		Romania	401103
45	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante	Spain	03203
46	Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia	Badalona	Barcelona	Spain	08916
47	Corporacio Sanitaria Parc Tauli; Servicio de Oncologia	Sabadell	Barcelona	Spain	8208
48	Clinica Universitaria de Navarra	Pamplona	Navarra	Spain	31008
49	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona		Spain	08035
50	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007
51	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid		Spain	28041
52	Hospital Madrid Norte Sanchinarro	Madrid		Spain	28050
53	Hospital Clinico Universitario Virgen de la Victoria	Malaga		Spain	29010
54	Queen Elizabeth Hospital; Centre for Clinical Haematology	Birmingham		United Kingdom	B15 2TH
55	Gartnavel General Hospital	Glasgow		United Kingdom	G12 0XH
56	St. James University Hospital; Pharmacy Department	Leeds		United Kingdom	LS9 7TF
57	The Clatterbridge Cancer Centre NHS Foundation Trust	Liverpool		United Kingdom	L7 8YA
58	Sarah Cannon Research Institute	London		United Kingdom	W1G 6AD
59	The Royal Marsden Hospital	Sutton		United Kingdom	SM2 5PT

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT01485861
• Other Study ID Numbers: GO27983; 2011-004126-10
• First Posted: Dec 6, 2011
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Prednisolone

Study Results

No Results Posted as of Jul 27, 2022