A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Corporation
Study ID
NCT01604889
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epacadostat — DRUG
  • ipilimumab — DRUG
    ipilimumab 3 mg/kg intravenous (IV)

Study Details

The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients. Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.

Key Dates

Start date
Mar 29, 2012
Status verified
Apr 2026
Primary completion
Dec 27, 2016
Completion
Jan 20, 2017

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Epacadostat 25 mg
    25 mg BID in combination with ipilimumab
  • Experimental: Epacadostat 50 mg
    50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off.
  • Experimental: Epacadostat 75 mg
    75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM).
  • Experimental: Epacadostat 100 mg
    100 mg twice daily (BID) in combination with ipilimumab
  • Experimental: Epacadostat 300 mg
    300 mg twice daily (BID) in combination with ipilimumab

Primary Outcome Measure

Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability. [ Time Frame: Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead). ]

Locations (7)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia--
-MiamiFlorida--
-TampaFlorida--
-ChicagoIllinois--
-DurhamNorth Carolina--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology

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