Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT02559492
Phase
PHASE1
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Itacitinib — DRUG
    Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
  • Epacadostat — DRUG
    Epacadostat tablets will be administered orally, twice daily.
  • Itacitinib — DRUG
    Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
  • INCB050465 — DRUG
    INCB050465 tablets will be administered orally once daily.

Study Details

This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.

Key Dates

Start date
Nov 30, 2015
Status verified
Sep 2019
Primary completion
Sep 10, 2018
Completion
Aug 18, 2019

Study Design

Enrollment
142 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Itacitinib + epacadostat
    Group A will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days.
  • Experimental: Group B: Itacitinib + INCB050465
    Group B will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through 21 days ]

Locations (11)

FacilityCityStateZIPSite coordinators
-DuarteCalifornia--
-DenverColorado--
-New HavenConnecticut--
-TampaFlorida--
-ChicagoIllinois--
-RochesterMinnesota--
-HuntersvilleNorth Carolina--
-NashvilleTennessee--
-DallasTexas--
-HoustonTexas--
-Salt Lake CityUtah--

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