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

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT02711137

Run by

Incyte Corporation

People needed

137

Starts

2016-05-18

Expected to finish

2019-02-13

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of California — La Jolla, California, United States
• Sarah Cannon Research Institute at Health One — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Hematology - Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Rochester, Wilmot Cancer Center — Rochester, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Oncology Consultants, P.A. — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• MultiCare Institute for Research and Innovation — Tacoma, Washington, United States
• Institut Jules Bordet, Clinical Trial Conduct Unit — Brussels, Belgium
• HÔPITAL SAINT-LOUIS, Service Hématologie Adultes — Paris, France

Full record on ClinicalTrials.gov

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