CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Satraplatindrug
Likely dose
Satraplatin 80mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01289067
NCT01289067Phase 2Completed

Predicting Response to Platinum Chemotherapy in Metastatic Castration Resistant Prostate Ca(mCRPC)Using a Genomic Signature for "BRCAness": A Phase II Prospective Open Label Clinical Trial of Satraplatin in Men With mCRPC Who Have Progressed on Docetaxel

William K. Oh·interventional·Posted Feb 3, 2011·Updated Feb 13, 2018

In Brief

A Phase 2 clinical trial evaluating Satraplatin for Prostate Cancer. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of the study is to test genes for BRCAness(BRCA\[BReast CAncer\] gene) Studying these genes could help predict which patients would benefit from treatment with satraplatin, a medication being used for subjects who have failed prior chemotherapy. All subjects will have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene signature may be able to predict response to satraplatin and a tool will be developed to be able to screen patients likely to benefit from satraplatin. Subjects will all receive Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered responders if they have measurable disease meeting criteria for partial or complete response. PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2011
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.4 years ago

Interventions

Satraplatindrug

Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days