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Hodgkin Lymphoma

INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.

Subjects allocated to Group B will be given INCB040093 BID in combination with itacitinib SR tablets. The dose of itacitinib will be orally given once daily (QD). Doses should be taken in the morning on an empty stomach if possible.

INCB040093 Monotherapy

INCB040093

The dose of itacitinib will be given orally once daily (QD).

itacitinib

Peter Langmuir, MD

A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with itacitinib (INCB039110) in subjects with relapsed or refractory Hodgkin Lymphoma.

INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma

A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With Itacitinib (INCB039110) in Subjects With Relapsed or Refractory Hodgkin Lymphoma

Evaluate the efficacy of INCB040093 as monotherapy and when given in combination with itacitinib by assessing the objective response rate (ORR) determined by an independent review committee.

Safety and tolerability of INCB040093 as monotherapy in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

Safety and tolerability of INCB040093 when given in combination with itacitinib in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

Complete Response is determined by the independent review committee and based on standard response criteria defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions.

Duration of response is defined as the time from the first assessment showing response (CR or PR) determined by the independent review committee to the first documented disease progression determined by the independent review committee or death due to any cause, whichever occurs first.

PFS was defined as the time from first dose to the first documented disease progression or relapse as assessed by independent review committee or death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma	NCT02456675	Refractory Hodg... Recurrent Adult...	INCB040093 Mono... INCB040093 itacitinib	18 Years -	Incyte Corporation
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma	NCT02456675	Refractory Hodg... Recurrent Adult...	INCB040093 Mono... INCB040093 itacitinib	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for recurrent adult hodgkin's lymphoma