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

Sponsor
Incyte Corporation
Study ID
NCT02456675
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Adult Hodgkin's Lymphoma
  • Refractory Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2015
Status verified
Jan 2018
Primary completion
Dec 16, 2016
Completion
Dec 16, 2016

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: INCB040093 Monotherapy
    INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
  • Experimental: INCB040093 and itacitinib (INCB039110) Combination Therapy
    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 Measure

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

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