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

January 8, 2018 updated by: Incyte Corporation

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
Measured every 9 weeks from baseline until progression (estimated to be 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
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
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]
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
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
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.
Week 36 disease evaluation
To evaluate the duration of response (DOR)
Time Frame: 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.
Week 36 disease evaluation
To evaluate the progression-free survival (PFS)
Time Frame: 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.
Week 36 disease evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40093-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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