A PHASE Ib/II STUDY OF IPATASERTIB (GDC-0068) OR APITILISIB (GDC-0980) WITH ABIRATERONE ACETATE VERSUS ABIRATERONE ACETATE IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH DOCETAXEL-BASED CHEMOTHERAPY

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Patients must meet all the following criteria to be eligible for study entry: 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 (e.g., 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.

Exclusion Criteria

* 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.
* Malabsorption syndrome or other condition that would interfere with
enteral absorption
* Congenital long QT syndrome or QTc > 480 msec

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Outcome Measure for PHASE II<br /><br>The primary efficacy outcome measure in all patients and in patients with PTEN<br /><br>loss is as follows:<br /><br>* Radiographic progression-free survival as the time from randomization to the<br /><br>first observation of disease progression, as assessed by the investigator, or<br /><br>death (* 30 days after the last dose of study treatment) from any cause on<br /><br>study.</p><br>

Secondary Outcome Measures