NCT02456675

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2016

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

March 19, 2015

Last Update Submit

January 8, 2018

Conditions

Refractory Hodgkin LymphomaRecurrent Adult Hodgkin's Lymphoma

Keywords

Refractory Hodgkin lymphomaRelapsed Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (5)

  • 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]

  • 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]

  • Percentage of subjects achieving a complete response (CR) determined by the independent review committee and based on standard response criteria

    Week 36 disease evaluation

  • To evaluate the duration of response (DOR)

    Week 36 disease evaluation

  • To evaluate the progression-free survival (PFS)

    Week 36 disease evaluation

Study Arms (2)

INCB040093 Monotherapy

EXPERIMENTAL

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

Drug: INCB040093 Monotherapy

INCB040093 and itacitinib (INCB039110) Combination Therapy

EXPERIMENTAL

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: INCB040093Drug: itacitinib

Interventions

INCB040093 MonotherapyDRUG

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

INCB040093 Monotherapy
INCB040093DRUG

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

INCB040093 and itacitinib (INCB039110) Combination Therapy
itacitinibDRUG

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

Also known as: INCB039110
INCB040093 and itacitinib (INCB039110) Combination Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hodgkin Disease

Interventions

itacitinibINCB039110

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Peter Langmuir, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

May 28, 2015

Study Start

June 1, 2015

Primary Completion

December 16, 2016

Study Completion

December 16, 2016

Last Updated

January 12, 2018

Record last verified: 2018-01