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A decision was made to terminate the study due to the changing treatment landscape for the development of new agents in combination in Hodgkin lymphoma.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCB040093 Monotherapy | Experimental | INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. |
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| INCB040093 and itacitinib (INCB039110) Combination Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB040093 Monotherapy | Drug | INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR) | 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. | Measured every 9 weeks from baseline until progression (estimated to be 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting adverse events in the monotherapy group | 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 | every 3 weeks for the duration of participation in the study [estimated to be 12 months] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Langmuir, MD | Incyte Corporation | Study Director |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
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| INCB040093 | Drug | INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. |
|
| itacitinib | Drug | The dose of itacitinib will be given orally once daily (QD). |
|
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| Percentage of participants reporting adverse events in the combination therapy group | 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 | every 3 weeks for the duration of participation in the study [estimated to be 12 months] |
| Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria | 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. | Week 36 disease evaluation |
| To evaluate the duration of response (DOR) | 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. | Week 36 disease evaluation |
| To evaluate the progression-free survival (PFS) | 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. | Week 36 disease evaluation |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |