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Trial record 1 of 1 for:    NCT03314935
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A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

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.
 
ClinicalTrials.gov Identifier: NCT03314935
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE October 16, 2017
First Posted Date  ICMJE October 19, 2017
Last Update Posted Date July 20, 2020
Actual Study Start Date  ICMJE November 20, 2017
Estimated Primary Completion Date October 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Phase 1: Participants with treatment-emergent adverse events (TEAE) [ Time Frame: 28 days ]
    TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
  • Phase 2: Objective response rate [ Time Frame: Every 8 weeks for duration of study participation which is estimated to be 18 months. ]
    Defined as the percentage of subjects having a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Phase 2: Participants with TEAEs [ Time Frame: Screening through 90 days after end of treatment, up to 21 months. ]
    TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
  • Phase 1: Objective response rate [ Time Frame: Every 8 weeks for duration of study participation, up to 18 months. ]
    Defined as the percentage of subjects having a CR or PR per RECIST v1.1.
  • Duration of response [ Time Frame: Every 8 weeks for duration of study participation, up to 18 months. ]
    Defined as the time from earliest date of CR or PR (per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if occurring sooner than disease progression.
  • Disease control rate [ Time Frame: Every 8 weeks for duration of study participation, up to 18 months. ]
    Defined as the percentage of subjects having CR, PR, or stable disease for at least 8 weeks (per RECIST v1.1).
  • Progression-free survival [ Time Frame: Every 8 weeks for duration of study participation, up to 18 months ]
    Defined as the time from date of first dose of study drug until the earliest date of disease progression (per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
Official Title  ICMJE A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors
Brief Summary The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Biliary Tract Cancer (BTC)
  • Colorectal Cancer (CRC)
  • Endometrial Cancer
  • Gastroesophageal Cancer (GC)
  • Ovarian Cancer
  • Solid Tumors
Intervention  ICMJE
  • Drug: INCB001158
    Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
    Other Name: Arginase inhibitor
  • Drug: Oxaliplatin
    Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
  • Drug: Leucovorin
    Leucovorin at the protocol-defined dose and regimen.
  • Drug: 5-Fluorouracil
    5-Fluorouracil at the protocol-defined dose and regimen.
  • Drug: Gemcitabine
    Gemcitabine at the protocol-defined dose and regimen.
  • Drug: Cisplatin
    Cisplatin at the protocol-defined dose and regimen.
  • Drug: Paclitaxel
    Paclitaxel at the protocol-defined dose and regimen.
Study Arms  ICMJE
  • Experimental: Treatment Group A
    INCB001158 + FOLFOX
    Interventions:
    • Drug: INCB001158
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: 5-Fluorouracil
  • Experimental: Treatment Group B
    INCB001158 + gemcitabine/cisplatin
    Interventions:
    • Drug: INCB001158
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • Experimental: Treatment Group C
    INCB001158 + paclitaxel
    Interventions:
    • Drug: INCB001158
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 17, 2020)
149
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
249
Estimated Study Completion Date  ICMJE October 6, 2021
Estimated Primary Completion Date October 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
  • Presence of measurable disease per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
  • Resolution of treatment-related toxicities.
  • Adequate hepatic, renal, cardiac, and hematologic function.
  • Additional cohort-specific criteria may apply.

Exclusion Criteria:

  • Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
  • Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
  • Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
  • Has received prior approved radiotherapy within 14 days of study therapy.
  • Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has an active infection requiring systemic therapy.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • Women who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03314935
Other Study ID Numbers  ICMJE INCB 01158-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sven Gogov, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date July 2020

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