NCT01289067

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

Completed Phase 2 Results posted Last updated 16 January 2018

What this trial tests

Phase 2 trial testing Satraplatin in Prostate Cancer in 13 participants. Completed in 1 May 2013.

Timeline

1 December 2010

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	William K. Oh
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 December 2010
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across United States

Drugs / interventions tested

• Satraplatin — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

William K. Oh

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy of Satraplatin as Second Line Therapy in Men With CRCP
  Time frame: 3 months
  Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Portrait of a cancer: mutational signature analyses for cancer diagnostics.
   Van Hoeck A, Tjoonk NH, van Boxtel R, Cuppen E. · · 2019 · cited 85× · PMID 31092228 · DOI 10.1186/s12885-019-5677-2
2. Phase II study of satraplatin and prednisone in patients with metastatic castration-resistant prostate cancer: a pharmacogenetic assessment of outcome and toxicity.
   Figg WD, Chau CH, Madan RA, Gulley JL, et al · · 2013 · cited 23× · PMID 23684781 · DOI 10.1016/j.clgc.2013.04.007
3. From the Discovery of Targets to Delivery Systems: How to Decipher and Improve the Metallodrugs' Actions at a Molecular Level.
   Iacobucci I, La Manna S, Cipollone I, Monaco V, et al · · 2023 · cited 6× · PMID 37514183 · DOI 10.3390/pharmaceutics15071997