Clinical trial NCT02456675: INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
Official title: A Phase 2, Open-Label Study of the Safety and Efficacy of INCB40093 and INCB40093 Combined With Itacitinib (INCB039110) in Subjects With Relapsed or Refractory Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Refractory Hodgkin Lymphoma
Recurrent Adult Hodgkin's Lymphoma
Keywords: Refractory Hodgkin lymphoma
Relapsed Hodgkin Lymphoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)
timeFrame: 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
timeFrame: every 3 weeks for the duration of participation in the study [estimated to be 12 months]
measure: Percentage of participants reporting adverse events in the combination therapy group
timeFrame: every 3 weeks for the duration of participation in the study [estimated to be 12 months]
measure: Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria
timeFrame: Week 36 disease evaluation
measure: To evaluate the duration of response (DOR)
timeFrame: Week 36 disease evaluation
measure: To evaluate the progression-free survival (PFS)
timeFrame: Week 36 disease evaluation
Other outcomes:
Locations:
Study officials:
affiliation: Incyte Corporation
name: Peter Langmuir, MD
role: STUDY_DIRECTOR
References: