Status: Closed
Activation Date: 2011APR04
Closing Date: 2014JAN10
Phase: II
Description: A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).
Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease.
Objective: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I205 | 68 | 44 | 18 | 60 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I205 | 68 | 1 | 2 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I205 | 68 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |