Back to resultsINCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
Primary Purpose
Refractory Hodgkin Lymphoma, Recurrent Adult Hodgkin's Lymphoma
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
INCB040093 Monotherapy
INCB040093
itacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Hodgkin Lymphoma focused on measuring Refractory Hodgkin lymphoma, Relapsed 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
INCB040093 Monotherapy
INCB040093 and itacitinib (INCB039110) Combination Therapy
Arm Description
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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.
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.
To evaluate the progression-free survival (PFS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02456675
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
A decision was made to terminate the study due to the changing treatment landscape for the development of new agents in combination in Hodgkin lymphoma.
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 16, 2016 (Actual)
Study Completion Date
December 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Hodgkin Lymphoma, Recurrent Adult Hodgkin's Lymphoma
Keywords
Refractory Hodgkin lymphoma, Relapsed Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB040093 Monotherapy
Arm Type
Experimental
Arm Description
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
Arm Title
INCB040093 and itacitinib (INCB039110) Combination Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
INCB040093 Monotherapy
Intervention Description
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
Intervention Type
Drug
Intervention Name(s)
INCB040093
Intervention Description
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
Intervention Type
Drug
Intervention Name(s)
itacitinib
Other Intervention Name(s)
INCB039110
Intervention Description
The dose of itacitinib will be given orally once daily (QD).
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)
Description
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 Outcome Measure Information:
Title
Percentage of participants reporting adverse events in the monotherapy group
Description
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]
Title
Percentage of participants reporting adverse events in the combination therapy group
Description
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]
Title
Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria
Description
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
Title
To evaluate the duration of response (DOR)
Description
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.
Time Frame
Week 36 disease evaluation
Title
To evaluate the progression-free survival (PFS)
Description
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.
Time Frame
Week 36 disease evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Langmuir, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
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