Indomethacin for Advanced Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Prostate Cancer+2 MoreIndomethacin - Drug
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is testing the side effects of enzalutamide and indomethacin on treating prostate cancer.

Eligible Conditions
  • Prostate Cancer
  • Advanced Prostate Cancer
  • Hormone-Refractory Prostate Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 3.5 years

Up to 3.5 years
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall response determined by PCWG2 criteria
Overall survival
PFS
PSA response rate defined as >= 50% decrease from the baseline

Trial Safety

Side Effects for

Indomethacin Patch
1%Gingival bleeding
1%Inflammation
1%Upper respiratory tract infections
1%Application site pruritis
1%Vascular rupture
1%Nasopharyngitis
1%Pruritis
1%Ligament sprain
1%Rash
1%Drug eruption
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01957215) in the Indomethacin Patch ARM group. Side effects include: Gingival bleeding with 1%, Inflammation with 1%, Upper respiratory tract infections with 1%, Application site pruritis with 1%, Vascular rupture with 1%.

Trial Design

1 Treatment Group

Treatment (enzalutamide, indomethacin)
1 of 1

Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Indomethacin · No Placebo Group · Phase 1 & 2

Treatment (enzalutamide, indomethacin)Experimental Group · 2 Interventions: Enzalutamide, Indomethacin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Indomethacin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3.5 years

Who is running the clinical trial?

Mamta ParikhLead Sponsor
3 Previous Clinical Trials
61 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,739 Total Patients Enrolled
1 Trials studying Advanced Prostate Cancer
23 Patients Enrolled for Advanced Prostate Cancer
Chong-Xian PanPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
1 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

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