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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer (BTC) Colorectal Cancer (CRC) Endometrial Cancer Gastroesophageal Cancer (GC) Ovarian Cancer Solid Tumors Drug: INCB001158 Drug: Oxaliplatin Drug: Leucovorin Drug: 5-Fluorouracil Drug: Gemcitabine Drug: Cisplatin Drug: Paclitaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : October 6, 2021
Estimated Study Completion Date : October 6, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group A
INCB001158 + FOLFOX
 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.
Experimental: Treatment Group B
INCB001158 + gemcitabine/cisplatin
 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: Gemcitabine
Gemcitabine at the protocol-defined dose and regimen.

Drug: Cisplatin
Cisplatin at the protocol-defined dose and regimen.
Experimental: Treatment Group C
INCB001158 + paclitaxel
 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: Paclitaxel
Paclitaxel at the protocol-defined dose and regimen.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314935


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294-3300
USA Mitchell Cancer Center
Mobile, Alabama, United States, 36604
United States, California
UC Davis - Comprehensive Cancer Centre
Sacramento, California, United States, 95817
United States, Georgia
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
START San Antonio
San Antonio, Texas, United States, 78229
Belgium
Grand Hopital de Charleroi - Department of Medical Oncology
Brussels, Belgium, 6000
Institut Jules Bordet - Clinical Trials Conduct Unit
Brussels, Belgium, B-1000
United Kingdom
UCL Cancer Institute
London, United Kingdom, WC1E 6BT
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Sven Gogov, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03314935    
Other Study ID Numbers: INCB 01158-203
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
INCB001158
arginase inhibitor
oxaliplatin
leucovorin
5 fluorouracil
gemcitabine
cisplatin
 paclitaxel
solid tumors
colorectal cancer
biliary tract cancer
gastroesophageal cancer
endometrial cancer
ovarian cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Biliary Tract Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases
Biliary Tract Diseases
Leucovorin
Gemcitabine
Paclitaxel
Fluorouracil
Oxaliplatin
Antineoplastic Agents, Phytogenic