Phase 2
Completed N=13
Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca
Source: ClinicalTrials.gov NCT01289067 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Efficacy of Satraplatin as Second Line Therapy in Men With CRCP — 4; 6; 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Satraplatin as Second Line Therapy in Men With CRCP |
4; 6; 3 | — |
| SECONDARY Number of Days to Maximum Decline in PSA |
165.5 | — |
| SECONDARY Progression Free Survival (PFS) |
206; 35 | — |
| SECONDARY Overall Survival |
570; 486 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically confirmed adenocarcinoma of the prostate.
- Radiographic evidence of metastatic disease (Bone scan, CT(Computerized Tomography) scan, or MRI(Magnetic Resonance Imaging) are acceptable) amenable to image-guided biopsy.
- Castrate levels of testosterone (testosterone 1,500/μl
- Platelets >100,000/μl
- GFR(glomerular Filtration Rate) >30 ml/min
- ALT(Alanine transaminase) and AST(Aspartate transaminase) ≤ 2.5 X upper limit of normal (ULN) or ≤ 5 X ULN in patients with liver metastasis
- Age > 18 years
- Ability to take oral medications (pills must be swallowed whole)
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document
- Patients must be willing to undergo an image-guided biopsy of a metastatic site on at least one occasion.
- Patient agrees to utilize contraception while enrolled in the trial
Exclusion Criteria
- Patients who have received prior treatment with a platinum chemotherapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), history of symptomatic congestive heart failure (NYHC (New York Heart Association Classification) III), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT(Super ventricular tachycardia)or any VT(ventricular tachycardia), or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with a medical contraindication to image-guided biopsies
- Patients with a severe allergic reaction to satraplatin compounds.
- Has a history of a prior malignancy with the exception of the following: adequately treated basal cell or squamous cell skin cancer, or other cancers for which the subject has been disease-free for at least 5 years.
- Has had radiation therapy within 30 days prior to being registered for protocol therapy.
Data sourced from ClinicalTrials.gov (NCT01289067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.