A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02760485|
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|NHL - Non-Hodgkin's Lymphoma||Drug: itacitinib Drug: ibrutinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase 1/2 Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: itacitinib + ibrutinib||
Phase 1 will evaluate itacitinib at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
Other Name: INCB039110Drug: ibrutinib
- Phase 1: Safety and tolerability as assessed by adverse events and changes in clinical and laboratory assessments [ Time Frame: Screening through 35 days after end of treatment, up to 6 months ]
- Phase 2: Efficacy as assessed by objective response rate (ORR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ]Defined as percentage of subjects achieving a complete or partial response based on radiographic assessment.
- Efficacy as assessed by duration of response (DOR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ]Defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
- Efficacy as assessed by progression-free survival (PFS) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ]Defined as date of enrollment to earliest date of disease progression based on radiographic assessment or death due to any cause.
- Efficacy as assessed by overall survival (OS) [ Time Frame: Every 12 weeks, up to 6 months ]Defined as date of enrollment until death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760485
|Contact: Incyte Corporation Call Center||1.855.463.3463|
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|Study Director:||Amit Pande, MD||Incyte Corporation|