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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Abiraterone

Apitolisib

Ipatasertib

Placebo

Prednisone

Prednisolone

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

HonorHealth Research Institute ? Bisgrove
Pacific Hematology Oncology Associates
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Florida Cancer Specialists; Sarasota
Kaiser Permanente Medical Ctr
Johns Hopkins Univ; Bunting Blaustein Cancer Center
Karmanos Cancer Institute
Urology Cancer Center & GU Research Network
New York Cancer and Blood Specialists - Setauket Medical Oncology
Weill Cornell Medical College
Carolina Urologic Research Center
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Masarykuv onkologicky ustav
Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie
Urocentrum Praha s.r.o.
Vseobecna fakultni nemocnice v Praze
Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni
ICO Paul Papin; Oncologie Medicale.
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Hia Du Val De Grace
Institut Curie; Oncologie Medicale
GH Paris Saint Joseph; Hopital De Jour Oncologie
Hopital d'Instruction des Armees de Begin
Institut Gustave Roussy; Departement Oncologie Medicale
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Univ General Hosp Heraklion; Medical Oncology
University Hospital of Larissa; Oncology
University Hospital of Patras Medical Oncology
Metropolitan Hospital; 2Nd Oncology Clinic
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Azienda Ospedaliera Istituti Ospitalieri
Irccs Ospedale San Raffaele;Oncologia Medica
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Ospedale S. Donato; Divisione Di Reumatologia
Het Nederlands Kanker Inst
Vu Medisch Centrum; Afdeling Longziekten
MC Haaglanden; Oncologie
UMC St Radboud
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Sf. Constantin Hospital; Oncology
Prof. Dr. Th. Burghele Clin Urology Hosp
Prof. Dr. I. Chiricuta Institute of Oncology
ONCOMED - Medical Centre
Municipal Hosp Turdal; Oncology
Hospital General Universitario de Elche; Servicio de Oncologia
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Clinica Universitaria de Navarra
Hospital General Universitario Gregorio Marañon
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Hospital Madrid Norte Sanchinarro
Hospital Clinico Universitario Virgen de la Victoria
Queen Elizabeth Hospital; Centre for Clinical Haematology
Gartnavel General Hospital
St. James University Hospital; Pharmacy Department
The Clatterbridge Cancer Centre NHS Foundation Trust
Sarah Cannon Research Institute
The Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Phase Ib: Ipatasertib 400 mg + abiraterone

Phase Ib: Apitolisib 30 mg + abiraterone

Phase II: Ipatasertib 400 mg + abiraterone

Phase II: Ipatasertib 200 mg + abiraterone

Phase II: Placebo + abiraterone

Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone

Arm Description

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.

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.

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.

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.

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.

Participants will receive ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.

Outcomes

Primary Outcome Measures

Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)

DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than [<] 500 per microliter) lasting greater than (>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for > 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.

Phase Ib: Percentage of Participants With Adverse Events (AEs)

An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib

RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D.

Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)

rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization).

Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss

rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.

Secondary Outcome Measures

Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone

Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone

Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone

Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone

Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone

Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone

Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone

Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Phase II: Overall Survival (ITT Population)

Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.

Phase II: Overall Survival in Participants With ICR IHC PTEN Loss

Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Percentage of Participants With PSA Progression (ITT Population)

PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.

Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss

PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Time to PSA Progression (ITT Population)

Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.

Phase II: Time to PSA Progression in Participants With ICR PTEN Loss

Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Percentage of Participants With PSA Response (ITT Population)

PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.

Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss

PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Percentage of Participants With Objective Response (ITT Population)

Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.

Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss

Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint.

Phase II: Duration of Tumor Response (ITT Population)

Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.

Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss

Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)

CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.

Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss

CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Percentage of Participants With CTC Conversion (ITT Population)

CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.

Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss

CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Percentage of Participants With Pain Progression (ITT Population)

Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).

Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss

Phase II: Time to Pain Progression (ITT Population)

Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).

Phase II: Time to Pain Progression in Participants With ICR PTEN Loss

Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".

Phase II: Percentage of Participants With Adverse Events (AEs)

Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone

Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Full Information

NCT ID

NCT01485861

First Posted

December 2, 2011

Last Updated

August 17, 2023

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01485861

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 11, 2012 (Actual)

Primary Completion Date

September 1, 2015 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase Ib: Ipatasertib 400 mg + abiraterone

Arm Type

Experimental

Arm Description

Arm Title

Phase Ib: Apitolisib 30 mg + abiraterone

Arm Type

Experimental

Arm Description

Arm Title

Phase II: Ipatasertib 400 mg + abiraterone

Arm Type

Experimental

Arm Description

Arm Title

Phase II: Ipatasertib 200 mg + abiraterone

Arm Type

Experimental

Arm Description

Arm Title

Phase II: Placebo + abiraterone

Arm Type

Placebo Comparator

Arm Description

Arm Title

Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Abiraterone

Intervention Description

Orally once daily

Intervention Type

Drug

Intervention Name(s)

Apitolisib

Intervention Description

Orally once daily

Intervention Type

Drug

Intervention Name(s)

Ipatasertib

Intervention Description

Orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Orally once daily

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Orally bid

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Intervention Description

Orally bid

Primary Outcome Measure Information:

Title

Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)

Description

Time Frame

Days 1 to 28 of Cycle 1 (Cycle length = 28 days)

Title

Phase Ib: Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

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 approximately 10 months).

Title

Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib

Description

Time Frame

Days 1 to 28 of Cycle 1 (Cycle length = 28 days)

Title

Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)

Description

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)

Title

Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss

Description

rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.

Time Frame

Secondary Outcome Measure Information:

Title

Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone

Description

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone

Description

Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)

Description

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)

Description

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)

Description

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)

Description

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib

Description

Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).

Time Frame

Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)

Title

Phase II: Overall Survival (ITT Population)

Description

Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.

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 8.9 years overall]) (cycle length = 28 days)

Title

Phase II: Overall Survival in Participants With ICR IHC PTEN Loss

Description

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 8.9 years overall]) (cycle length = 28 days)

Title

Phase II: Percentage of Participants With PSA Progression (ITT Population)

Description

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)

Title

Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss

Description

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)

Title

Phase II: Time to PSA Progression (ITT Population)

Description

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)

Title

Phase II: Time to PSA Progression in Participants With ICR PTEN Loss

Description

Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "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)

Title

Phase II: Percentage of Participants With PSA Response (ITT Population)

Description

PSA response was defined as a > 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.

Time Frame

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)

Title

Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss

Description

Time Frame

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)

Title

Phase II: Percentage of Participants With Objective Response (ITT Population)

Description

Time Frame

Title

Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss

Description

Time Frame

Title

Phase II: Duration of Tumor Response (ITT Population)

Description

Time Frame

Title

Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss

Description

Time Frame

Title

Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)

Description

CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.

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)

Title

Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss

Description

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)

Title

Phase II: Percentage of Participants With CTC Conversion (ITT Population)

Description

CTC conversion was defined as a decline to < 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.

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)

Title

Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss

Description

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)

Title

Phase II: Percentage of Participants With Pain Progression (ITT Population)

Description

Time Frame

Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Title

Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss

Description

Time Frame

Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Title

Phase II: Time to Pain Progression (ITT Population)

Description

Time Frame

Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Title

Phase II: Time to Pain Progression in Participants With ICR PTEN Loss

Description

Time Frame

Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)

Title

Phase II: Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)

Title

Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone

Time Frame

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)

Title

Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations

Description

G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.

Time Frame

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)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

HonorHealth Research Institute ? Bisgrove

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Pacific Hematology Oncology Associates

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901-8101

Country

United States

Facility Name

Florida Cancer Specialists; Sarasota

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Kaiser Permanente Medical Ctr

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

Johns Hopkins Univ; Bunting Blaustein Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Urology Cancer Center & GU Research Network

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

New York Cancer and Blood Specialists - Setauket Medical Oncology

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Carolina Urologic Research Center

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Masarykuv onkologicky ustav

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie

City

Hradec Kralove

ZIP/Postal Code

50012

Country

Czechia

Facility Name

Urocentrum Praha s.r.o.

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni

City

Praha

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

ICO Paul Papin; Oncologie Medicale.

City

Angers

ZIP/Postal Code

49055

Country

France

Facility Name

Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

Hia Du Val De Grace

City

Paris

ZIP/Postal Code

75230

Country

France

Facility Name

Institut Curie; Oncologie Medicale

City

Paris

ZIP/Postal Code

75231

Country

France

Facility Name

GH Paris Saint Joseph; Hopital De Jour Oncologie

City

Paris

ZIP/Postal Code

75674

Country

France

Facility Name

Hopital d'Instruction des Armees de Begin

City

Saint-Mande

ZIP/Postal Code

94160

Country

France

Facility Name

Institut Gustave Roussy; Departement Oncologie Medicale

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Univ General Hosp Heraklion; Medical Oncology

City

Heraklion

ZIP/Postal Code

711 10

Country

Greece

Facility Name

University Hospital of Larissa; Oncology

City

Larissa

ZIP/Postal Code

413 35

Country

Greece

Facility Name

University Hospital of Patras Medical Oncology

City

Patras

ZIP/Postal Code

265 04

Country

Greece

Facility Name

Metropolitan Hospital; 2Nd Oncology Clinic

City

Piraeus

ZIP/Postal Code

185 47

Country

Greece

Facility Name

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

City

Meldola

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

Azienda Ospedaliera Istituti Ospitalieri

City

Cremona

State/Province

Lombardia

ZIP/Postal Code

26100

Country

Italy

Facility Name

Irccs Ospedale San Raffaele;Oncologia Medica

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Ospedale S. Donato; Divisione Di Reumatologia

City

Arezzo

State/Province

Toscana

ZIP/Postal Code

52100

Country

Italy

Facility Name

Het Nederlands Kanker Inst

City

Amsterdam

ZIP/Postal Code

1066 EC

Country

Netherlands

Facility Name

Vu Medisch Centrum; Afdeling Longziekten

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

MC Haaglanden; Oncologie

City

Den Haag

ZIP/Postal Code

2512 VA

Country

Netherlands

Facility Name

UMC St Radboud

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Sint Franciscus Gasthuis; Inwendige Geneeskunde

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

Sf. Constantin Hospital; Oncology

City

Brasov

ZIP/Postal Code

500019

Country

Romania

Facility Name

Prof. Dr. Th. Burghele Clin Urology Hosp

City

Bucharest

ZIP/Postal Code

050659

Country

Romania

Facility Name

Prof. Dr. I. Chiricuta Institute of Oncology

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

ONCOMED - Medical Centre

City

Timisoara

ZIP/Postal Code

300239

Country

Romania

Facility Name

Municipal Hosp Turdal; Oncology

City

Turda

ZIP/Postal Code

401103

Country

Romania

Facility Name

Hospital General Universitario de Elche; Servicio de Oncologia

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

8208

Country

Spain

Facility Name

Hospital Univ Vall d'Hebron; Servicio de Oncologia

City

Sant Andreu de La Barca

State/Province

Barcelona

ZIP/Postal Code

08740

Country

Spain

Facility Name

Clinica Universitaria de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre; Servicio de Oncologia

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Madrid Norte Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Clinico Universitario Virgen de la Victoria

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Queen Elizabeth Hospital; Centre for Clinical Haematology

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Gartnavel General Hospital

City

Glasgow

ZIP/Postal Code

G12 0XH

Country

United Kingdom

Facility Name

St. James University Hospital; Pharmacy Department

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

The Clatterbridge Cancer Centre NHS Foundation Trust

City

Liverpool

ZIP/Postal Code

L7 8YA

Country

United Kingdom

Facility Name

Sarah Cannon Research Institute

City

London

ZIP/Postal Code

W1G 6AD

Country

United Kingdom

Facility Name

The Royal Marsden Hospital

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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