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

NCT02559492 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2019-09-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Itacitinib

Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.

DRUG

Epacadostat

Epacadostat tablets will be administered orally, twice daily.

DRUG

Itacitinib

Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.

DRUG

INCB050465

INCB050465 tablets will be administered orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Lance Leopold, MD · Incyte Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-09-10
Completion
2019-08-18

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02559492 on ClinicalTrials.gov