Overview

This trial is active, not recruiting.

Conditions refractory hodgkin lymphoma, recurrent adult hodgkin's lymphoma
Treatments incb040093 monotherapy, incb040093, incb039110
Phase phase 2
Sponsor Incyte Corporation
Start date June 2015
End date January 2018
Trial size 122 participants
Trial identifier NCT02456675, 40093-201

Summary

A Phase 2, open-label study to evaluate the safety and efficacy of INCB040093 as monotherapy and as combination therapy with INCB039110 in subjects with relapsed or refractory Hodgkin Lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
incb040093 monotherapy
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
(Experimental)
Subjects allocated to Group B will be given INCB040093 BID in combination with INCB039110 SR tablets. The dose of INCB039110 will be orally given once daily (QD). Doses should be taken in the morning on an empty stomach if possible.
incb040093
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
incb039110
The dose of INCB039110 will be given orally once daily (QD).

Primary Outcomes

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)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With INCB039110 in Subjects With Relapsed or Refractory Hodgkin Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.
Location data was received from the National Cancer Institute and was last updated in July 2016.