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

• Status: Terminated
• Trial end date: 2016-12-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.