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 Chemotherapy

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 260

Inclusion Criteria

Patients must meet all the following criteria to be eligible for study
entry:
· Signed Informed Consent Form(s)
· Age =18 years
· 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 (luteinizing hormone-releasing hormone, bicalutamide, etc.)
· Availability at the site of a representative formalin-fixed, paraffinembedded tumor specimen that enabled the definitive diagnosis of prostate cancer, accompanied by an associated pathology report (required prior to randomization)
The specimen must contain adequate viable tumor cells (eg. a minimum of 50 viable tumor cells or tumor tissue derived from prostatectomy or = 50% tumor content if sample is a core biopsy).
Specimen may consist of a tissue block (preferred) or 15-20 unstained,
serial slides. Cytologic or fine-needle aspiration samples are not
acceptable. If archival tissue is either insufficient or unavailable, the
patient may still be eligible, upon discussion with the Medical Monitor,
assuming the patient Can provide = 5 unstained, serial slides
or
Is willing to consent to and undergo a pretreatment core or excisional
biopsy of the tumor (if fresh biopsy is permitted by local regulatory authorities and ethics committees). Cytologic or fine-needle aspiration samples are not
acceptable.
· Two rising PSA levels = 2 ng/mL measured = 1 week apart during or
following the most recent prior therapy for prostate cancer that meet the
Prostate Cancer Working Group 2 (PCWG2) criteria for progression
before initiation of study treatment or radiographic evidence of disease
progression in soft tissue or bone, with or without disease progression
on the basis of the PSA value

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from
study entry:
· Small cell or neuroendocrine prostate carcinoma
· History of Type I or Type II diabetes mellitus requiring insulin
Patients who are on a stable dose of oral diabetes medication = 4 weeks
prior to initiation of study treatment may be eligible for enrollment.
· Inability or unwillingness to swallow pills
· Malabsorption syndrome or other condition that would interfere with
enteral absorption
· Congenital long QT syndrome or QTc > 480 msec

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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