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

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02456675
• Collaborator: (none)
• Enrollment: 8
• Arms: 2
• Actual Duration (Months): 18.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Hodgkin Lymphoma; Recurrent Adult Hodgkin's Lymphoma	Drug: INCB040093 Monotherapy; Drug: INCB040093; Drug: itacitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 16, 2016
• Actual Study Completion Date: Dec 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INCB040093 Monotherapy INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.	Drug: 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.	Drug: INCB040093; INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.; Drug: itacitinib; The dose of itacitinib will be given orally once daily (QD).; Other Names: INCB039110

Outcome Measures

Primary Outcome Measures

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

   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.

Secondary Outcome Measures

1. Percentage of participants reporting adverse events in the monotherapy group [every 3 weeks for the duration of participation in the study [estimated to be 12 months]]

   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

2. Percentage of participants reporting adverse events in the combination therapy group [every 3 weeks for the duration of participation in the study [estimated to be 12 months]]

   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

3. Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria [Week 36 disease evaluation]

   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.

4. To evaluate the duration of response (DOR) [Week 36 disease evaluation]

   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.

5. To evaluate the progression-free survival (PFS) [Week 36 disease evaluation]

   PFS was defined as the time from first dose to the first documented disease progression or relapse as assessed by independent review committee or death from any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Incyte Corporation

Investigators

• Study Director: Peter Langmuir, MD, Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT02456675
• Other Study ID Numbers: 40093-201
• First Posted: May 28, 2015
• Last Update Posted: Jan 12, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Incyte Corporation: Refractory Hodgkin lymphoma; Relapsed Hodgkin Lymphoma
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease

Study Results

No Results Posted as of Jan 12, 2018