Trial Outcomes & Findings for Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca (NCT NCT01289067)

Last Updated: 2018-02-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

3 months

Results posted on

2018-02-13

Participant Flow

Recruitment began in December 2010. Thirteen (13) patients from Mount Sinai Medical Center were enrolled to the study between January 27, 2011 and March 7, 2013.

Participant milestones

Participant milestones
Measure	Satraplatin, Single Arm Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Satraplatin, Single Arm n=13 Participants Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Metastasis site Bone only	6 participants n=5 Participants
Metastasis site Lymph Node only	4 participants n=5 Participants
Metastasis site Visceral only	0 participants n=5 Participants
Metastasis site Bone and Lymph Node	1 participants n=5 Participants
Metastasis site Bone and Visceral	3 participants n=5 Participants
Metastasis site Lymph Node and Visceral	1 participants n=5 Participants
Metastasis site Bone, Lymph Node, and Visceral	2 participants n=5 Participants
Gleason Score Gleason 7	4 participants n=5 Participants
Gleason Score Gleason 8	5 participants n=5 Participants
Gleason Score Gleason 9	4 participants n=5 Participants
PSA	71.67 ng/ml n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Satraplatin, Single Arm n=13 Participants Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Efficacy of Satraplatin as Second Line Therapy in Men With CRCP non-responders	6 participants
Efficacy of Satraplatin as Second Line Therapy in Men With CRCP not evaluable for response	3 participants
Efficacy of Satraplatin as Second Line Therapy in Men With CRCP responders	4 participants

SECONDARY outcome

Timeframe: baseline and 3 months

Population: Only responders included

Response rate - Maximum decline in PSA that occurs during treatment.

Outcome measures

Outcome measures
Measure	Satraplatin, Single Arm n=4 Participants Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Number of Days to Maximum Decline in PSA	165.5 days Interval 68.0 to 236.0

SECONDARY outcome

Timeframe: up to 2 years

Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression.

Outcome measures

Outcome measures
Measure	Satraplatin, Single Arm n=13 Participants Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Progression Free Survival (PFS) Responders	206 days Interval 73.0 to 356.0
Progression Free Survival (PFS) Nonresponders	35 days Interval 31.0 to 41.0

SECONDARY outcome

Timeframe: 24 months

Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.

Outcome measures

Outcome measures
Measure	Satraplatin, Single Arm n=13 Participants Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Survival Responders	570 days Interval 184.0 to 717.0
Overall Survival Nonresponders	486 days Interval 147.0 to 644.0

Adverse Events

Satraplatin, Single Arm

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Satraplatin, Single Arm n=13 participants at risk Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Blood and lymphatic system disorders Leukopenia	23.1% 3/13
Blood and lymphatic system disorders Neutropenia	7.7% 1/13
Blood and lymphatic system disorders Thromboscytopenia	7.7% 1/13
General disorders Fatigue	7.7% 1/13
Renal and urinary disorders Renal failure	7.7% 1/13
General disorders Dysphagia	15.4% 2/13
Gastrointestinal disorders Diarrhea	7.7% 1/13

Additional Information

Dr. Bobby Liaw

Icahn School of Medicine at Mount Sinai

Phone: (212) 604-6010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place