We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02559492
First Posted: September 24, 2015
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Incyte Corporation
September 23, 2015
September 24, 2015
July 13, 2017
November 2015
December 2017   (Final data collection date for primary outcome measure)
Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through 21 days ]
Safety and tolerability of the treatment groups.
Same as current
Complete list of historical versions of study NCT02559492 on ClinicalTrials.gov Archive Site
  • Objective response rate (ORR) [ Time Frame: Every 9 weeks for duration of study participation which is estimated to be 18 months ]
    Tumor response rates in those subjects with measurable disease.
  • Progression Free Survival (PFS) [ Time Frame: Every 9 weeks for duration of study participation which is estimated to be 18 months ]
    Progression-free survival, defined as the time from enrollment until the earliest date of disease progression.
  • Duration of response (DOR) [ Time Frame: Every 9 weeks for duration of study participation which is estimated to be 18 months ]
    Duration of response determined by radiographic disease assessment.
Same as current
Not Provided
Not Provided
 
Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors
A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of INCB Combinations in Advanced Solid Tumors
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 2 parts (Part 1a and Part 1b). 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).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: Itacitinib
    Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
    Other Name: INCB039110
  • Drug: Epacadostat
    Epacadostat tablets will be administered orally, twice daily.
  • Drug: INCB050465
    INCB050465 tablets will be administered orally once daily.
  • 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.
    Interventions:
    • Drug: Itacitinib
    • Drug: Epacadostat
  • 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.
    Interventions:
    • Drug: Itacitinib
    • Drug: INCB050465
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
114
June 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • Has baseline tumor biopsy specimen available or willingness to undergo a pre-treatment tumor biopsy to obtain the specimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02559492
39110-106
No
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Hiroomi Tada, MD Incyte Corporation
Incyte Corporation
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP