A Phase 1/2, Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Overview

This is an open-label, dose-escalation/dose-expansion study of INCB057643 in subjects with advanced malignancies.

  • Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity.

  • Part 2 will further evaluate the safety, preliminary efficacy, pharmacokinetics, and pharmacodynamics of the dose(s) selected in Part 1 in select tumor types.

SparkCures ID 799
Trial Phase Phase 1/2
Enrollment 155 Patients
Treatments
  • INCB057643
Trial Sponsors
  • Incyte Corporation
NCT Identifier

NCT02711137

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced malignancy:
    • Part 1: advanced solid tumor or hematologic malignancy
    • Part 2: histologically confirmed disease in specific tumor types
  • Progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)
  • Life expectancy > 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status
    • Part 1: 0 or 1
    • Part 2: 0, 1, or 2
  • Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

  • Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
  • Inadequate organ function per protocol-specified total bilirubin, AST and ALT, and creatinine clearance
  • Receipt of anticancer medications or investigational drugs within protocol-specified intervals
  • Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant
  • Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment
  • Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
  • Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
  • Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
  • Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
  • History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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