Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03361228
Other study ID # INCB 01158-202
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2018
Est. completion date March 30, 2019

Study information

Verified date May 2020
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date March 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).

- For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.

- Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

- Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with = Grade 2 neuropathy are an exception and may enroll.

- Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within = 7 days before treatment initiation.

Exclusion Criteria:

- Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose.

- Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.

- Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.

- Prior therapy with an IDO1 or arginase 1 inhibitor.

- Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

- Receipt of a live vaccine within 30 days before the first dose of study treatment.

- Any history of serotonin syndrome after receiving serotonergic drugs.

- Use of protocol-defined prior/concomitant therapy.

- Known or suspected defect in the function of the urea cycle.

- History of gastrointestinal condition that may affect drug absorption.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Epacadostat
Epacadostat at the protocol-defined dose administered orally twice daily.
Pembrolizumab
Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.

Locations

Country Name City State
United States University of Alabama Birmingham Alabama
United States The University of Chicago Medicine Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE) TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment. Up to approximately 12 months per subject
Primary Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Up to approximately 12 months per subject
Secondary Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment. Up to approximately 12 months per subject
Secondary Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1. Up to approximately 12 months per subject
Secondary Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1. Up to approximately 12 months per subject
Secondary Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression. Up to approximately 12 months per subject
Secondary Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression. Up to approximately 12 months per subject
Secondary Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat. Up to approximately 1 month
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00750841 - Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours Phase 1
Withdrawn NCT05419817 - Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System Phase 2
Completed NCT02828930 - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) Phase 1
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Completed NCT03258515 - A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers Phase 1
Terminated NCT03225105 - M3541 in Combination With Radiotherapy in Solid Tumors Phase 1
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT03634982 - Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors Phase 1
Recruiting NCT04685226 - A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT06036121 - A Study of ADRX-0706 in Select Advanced Solid Tumors Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT01528046 - Metformin in Children With Relapsed or Refractory Solid Tumors Phase 1
Recruiting NCT05325866 - A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Phase 1/Phase 2
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Completed NCT02279433 - A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b Phase 1