Trial record 1 of 1 for: Vicus VT1-SYS
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Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
This study is currently recruiting participants.
Verified March 2014 by Vicus Therapeutics
Information provided by (Responsible Party):
First received: May 15, 2013
Last updated: March 6, 2014
Last verified: March 2014
The purpose of this study is to evaluate the clinical benefit of the co-administration of propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate cancer.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Vicus Therapeutics:
Primary Outcome Measures:
- Change in prostate specific antigen (PSA) [ Time Frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PSA progression [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
- PSA doubling time (PSADT) [ Time Frame: baseline and every month during treatment ] [ Designated as safety issue: No ]
- Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage) [ Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment ] [ Designated as safety issue: No ]
- Time to symptom progression (TTSP) [ Time Frame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle ] [ Designated as safety issue: No ]
- Change in correlative biomarkers [ Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: VT-122 with physician's choice therapy
Participants will receive oral doses of 66 mg propranolol and 680 mg etodolac daily. Propranolol will be administered 44 mg with breakfast and 22 mg in the mid-afternoon (3PM). Etodolac will be administered 340 mg with breakfast and 340 mg with dinner.
The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
Placebo Comparator: Placebo with physician's choice therapy
Participants will receive physician's choice therapy as the standard of care as well as the placebo capsules that are of the same weight as propranolol and etodolac.
The placebo capsules will be prepared to match the active drug.
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