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Trial record 12 of 1175 for:    "Hodgkin lymphoma"

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

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ClinicalTrials.gov Identifier: NCT02456675
Recruitment Status : Terminated (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.)
First Posted : May 28, 2015
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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 Type : Interventional  (Clinical Trial)
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 : June 2015
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : December 16, 2016

Resource links provided by the National Library of Medicine


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 Name: INCB039110




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456675


Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Peter Langmuir, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02456675     History of Changes
Other Study ID Numbers: 40093-201
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Incyte Corporation:
Refractory Hodgkin lymphoma
Relapsed Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases