Symptoms and General Pathology

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Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

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.

Incyte Corporation

Escalating doses starting at 100 mg every day (QD)

INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.

INCB040093 + itacitinib

The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and itacitinib (INCB039110), a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with itacitinib (INCB039110) in subjects with relapsed/refractory B-cell malignancies.

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

Plasma concentrations of each INCB040093 and itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies	NCT01905813	B-cell Malignan...	INCB040093 INCB040093 + it...	18 Years -	Incyte Corporation

Spots Global Cancer Trial Database for incb040093

Every month we try and update this database with for incb040093 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for incb040093

Every month we try and update this database with for incb040093 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for incb040093 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.