NCT02559492

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

September 23, 2015

Last Update Submit

September 23, 2019

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Dose Limiting Toxicities (DLTs)

    Safety and tolerability of the treatment groups.

    Baseline through 21 days

Secondary Outcomes (3)

  • Objective response rate (ORR)

    Every 9 weeks for duration of study participation which is estimated to be 18 months

  • Progression Free Survival (PFS)

    Every 9 weeks for duration of study participation which is estimated to be 18 months

  • Duration of response (DOR)

    Every 9 weeks for duration of study participation which is estimated to be 18 months

Study Arms (2)

Group A: Itacitinib + epacadostat

EXPERIMENTAL

Group A will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days.

Drug: ItacitinibDrug: Epacadostat

Group B: Itacitinib + INCB050465

EXPERIMENTAL

Group B will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days.

Drug: ItacitinibDrug: INCB050465

Interventions

ItacitinibDRUG

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

Also known as: INCB039110
Group A: Itacitinib + epacadostat
EpacadostatDRUG

Epacadostat tablets will be administered orally, twice daily.

Group A: Itacitinib + epacadostat
INCB050465DRUG

INCB050465 tablets will be administered orally once daily.

Group B: Itacitinib + INCB050465

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age 18 years or older.
  • Willingness to provide written informed consent for the study.
  • Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
  • Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
  • Part 1b: Must have documented confirmed disease progression on a prior programmed cell death-1 (PD-1) pathway targeted agent or must be PD-1 pathway-targeted treatment naïve.
  • Part 2: Subjects with HNSCC, NSCLC, pancreatic ductal adenocarcinoma, salivary gland cancer, and transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, have been intolerant to treatment, or have refused standard treatment.
  • Willingness to undergo a pre-treatment and on-treatment tumor biopsy to obtain the specimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

  • Laboratory parameters not within the protocol-defined range.
  • Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
  • Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
  • Has not recovered from toxic effect of prior therapy to \< Grade 1.
  • Active or inactive autoimmune process.
  • Has received a live vaccine within 30 days of planned start of study therapy.
  • Active infection requiring systemic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Duarte, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Huntersville, North Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Related Publications (1)

  • Naing A, Powderly JD, Nemunaitis JJ, Luke JJ, Mansfield AS, Messersmith WA, Sahebjam S, LoRusso PM, Garrido-Laguna I, Leopold L, Geschwindt R, Ding K, Smith M, Berlin JD. Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study. J Immunother Cancer. 2022 Mar;10(3):e004223. doi: 10.1136/jitc-2021-004223.

    PMID: 35288468DERIVED

MeSH Terms

Interventions

itacitinibINCB039110epacadostatparsaclisib

Study Officials

  • Lance Leopold, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 24, 2015

Study Start

November 1, 2015

Primary Completion

September 10, 2018

Study Completion

August 18, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

US(11)