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

Phase 2

Terminated

• Conditions: Refractory Hodgkin Lymphoma; Recurrent Adult Hodgkin's Lymphoma
• Interventions: Drug: INCB040093 Monotherapy; Drug: INCB040093; Drug: itacitinib

• Registration Number: NCT02456675
• Lead Sponsor: Incyte Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-28
• Study Start: 2015-06
• Primary Completion: 2016-12-16
• Study Completion: 2016-12-16
• Status Verified: 2018-01
• Disposition First Submitted: 2018-01-08
• Disposition First Submitted QC: 2018-01-08
• Last Update Submitted: 2018-01-08
• Disposition First Posted: 2018-01-12
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Men and women, aged 18 years or older
• Histologically confirmed diagnosis of classical HL
• Must be relapsed or refractory after autologous stem cell transplant (ASCT) and/or 2 or more prior chemotherapy regimens
• Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin
• Eastern Cooperative Oncology Group (ECOG) 0 to 2

Exclusion Criteria

• Laboratory parameters not within the protocol-defined range
• Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
• Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
• Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy
• Received autologous stem cell transplant within 28 days or allogeneic transplant within 3 months prior to first dose of study drug
• History of lymphoma involving the central nervous system
• Evidence of active or prior hepatitis infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
INCB040093 Monotherapy	INCB040093 Monotherapy	INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
INCB040093 and itacitinib (INCB039110) Combination Therapy	itacitinib	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 and itacitinib (INCB039110) Combination Therapy	INCB040093	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)	Measured every 9 weeks from baseline until progression (estimated to be 12 months)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria	Week 36 disease evaluation	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.
To evaluate the duration of response (DOR)	Week 36 disease evaluation	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.
Percentage of participants reporting adverse events in the monotherapy group	every 3 weeks for the duration of participation in the study [estimated to be 12 months]	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
Percentage of participants reporting adverse events in the combination therapy group	every 3 weeks for the duration of participation in the study [estimated to be 12 months]	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
To evaluate the progression-free survival (PFS)	Week 36 disease evaluation	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.