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

Incyte

Status and phase: Terminated; Phase 2

Conditions: Recurrent Adult Hodgkin's Lymphoma; Refractory Hodgkin Lymphoma

Treatments: Drug: INCB040093 Monotherapy; Drug: itacitinib; Drug: INCB040093

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456675

40093-201

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

INCB040093 Monotherapy

Experimental group

Description:

INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.

Treatment:

Drug: INCB040093 Monotherapy

INCB040093 and itacitinib (INCB039110) Combination Therapy

Experimental group

Description:

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.

Treatment:

Drug: INCB040093

Drug: itacitinib