Skip to main content

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Trial Status: Administratively Complete

The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for 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, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies:
  • Part 1: solid tumors or lymphomas, or hematologic malignancies
  • Part 2: histologically confirmed disease in specific tumor types
  • Part 3: advanced solid tumor or hematologic malignancy
  • Part 4: select advanced solid tumor or hematologic malignancy
  • For Part 1 and 2, subjects must have 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)
  • For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort.
  • Life expectancy > 12 weeks, for MF subjects in Parts 3 and 4, life expectancy > 24 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status
  • Parts 1 and 3: 0 or 1
  • Parts 2 and 4: 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, creatinine clearance and alkaline phosphatase.
  • 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
  • Type 1 diabetes or uncontrolled Type 2 diabetes
  • HbA1c of ≥ 8% (all subjects will have HbA1c test at screening)
  • Any sign of clinically significant bleeding
  • Coagulation panel within protocol-specified parameters

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL

California

San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: COMPLETED

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: COMPLETED

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: COMPLETED

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: COMPLETED

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Incyte Corporation

  • Primary ID INCB 57643-101
  • Secondary IDs NCI-2016-01069
  • Clinicaltrials.gov ID NCT02711137