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

Phase 2TerminatedNCT02456675

Incyte Corporation8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Refractory Hodgkin Lymphoma Recurrent Adult Hodgkin's Lymphoma

Interventions

INCB040093 MonotherapyDRUG

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

INCB040093DRUG

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

itacitinibDRUG

The dose of itacitinib will be given orally once daily (QD).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)

Evaluate the efficacy of INCB040093 as monotherapy and when given in combination with itacitinib by assessing the objective response rate (ORR) determined by an independent review committee.

Time frame: Measured every 9 weeks from baseline until progression (estimated to be 12 months)

Secondary Outcomes

Percentage of participants reporting adverse events in the monotherapy group

Safety and tolerability of INCB040093 as monotherapy in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

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

Safety and tolerability of INCB040093 when given in combination with itacitinib in subjects with relapsed or refractory Hodgkin's lymphoma (HL) as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events

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

Complete Response is determined by the independent review committee and based on standard response criteria defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions.

Time frame: Week 36 disease evaluation

To evaluate the duration of response (DOR)

Duration of response is defined as the time from the first assessment showing response (CR or PR) determined by the independent review committee to the first documented disease progression determined by the independent review committee or death due to any cause, whichever occurs first.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.