TerminatedPhase 1/2

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

Stopped: Study terminated due to safety issues.

United States137 participantsStarted 2016-05-18

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAE's).

Timeframe: From screening through at least 30 days after end of treatment, up to approximately 24 months

Trial details

NCT IDNCT02711137

SponsorIncyte Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-02-13

Results submitted2022-02-11