Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca

NCT01289067 | Completed Phase 2 Results DMC

• 2 other identifiers: GCO 10-1222Prostate Cancer Foundation
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Metastatic; Castration Resistant; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of Satraplatin as Second Line Therapy in Men With CRCP

  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.

  3 months

Secondary Outcomes (3)

• Number of Days to Maximum Decline in PSA

  baseline and 3 months

• Progression Free Survival (PFS)

  up to 2 years

• Overall Survival

  24 months

Study Arms (1)

Satraplatin, Single Arm

OTHER

Drug: Satraplatin

Interventions

Satraplatin DRUG

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

Also known as: JM-118

Satraplatin, Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<50 ng/dL) on androgen deprivation therapy (ADT). LHRH(luteinizing hormone releasing hormone)agonist therapy must continue while on study unless patient has previously undergone an orchiectomy.
• The patient must have discontinued antiandrogens (bicalutamide, flutamide or nilutamide) 30 days prior to baseline PSA.
• Progression on at least one line of a prior docetaxel-based chemotherapy.
• Patients must have adequate organ and marrow function as defined below:
• Absolute neutrophil count \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• William K. Oh: lead
• Prostate Cancer Foundation: collaborator

Study Sites (1)

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

satraplatin; amminedichloro(cyclohexylamine)platinum(II)

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

limitation include low sample size

Results Point of Contact

• Title: Dr. Bobby Liaw
• Organization: Icahn School of Medicine at Mount Sinai

bobby.liaw@mountsinai.org

(212) 604-6010

Study Officials

• William K Oh, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Division of Hematology/Medical Oncology

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: February 3, 2011
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 13, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-01

Locations

US (1)