Refractory Hodgkin LymphomaPhase 2NCT02456675
INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
A Phase 2 study testing INCB040093 Monotherapy, INCB040093 and itacitinib in people with Refractory Hodgkin Lymphoma and Recurrent Adult Hodgkin's Lymphoma, run by Incyte Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Hodgkin Lymphoma, Recurrent Adult Hodgkin's Lymphoma
- What is being tested?
- INCB040093 Monotherapy, INCB040093 and itacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 16 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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
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.
- Being tested
- INCB040093 Monotherapy, INCB040093, itacitinib
- Keywords
- Refractory Hodgkin lymphoma, Relapsed Hodgkin Lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB040093 MonotherapyDrug
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
INCB040093Drug
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
itacitinibDrug
Also called INCB039110
The dose of itacitinib will be given orally once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| INCB040093 Monotherapy | Experimental | INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. Receives: 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. Receives: Drug: INCB040093; Drug: itacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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
Measured: 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
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
Measured: 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
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.
Measured: Week 36 disease evaluation
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.
Measured: Week 36 disease evaluation
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.
Measured: Week 36 disease evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJun 2015
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Langmuir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456675
- Sponsor's protocol ID
- 40093-201
- Status last verified
- Jan 2018
- First submitted
- 19 Mar 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02456675
- Acronym / sponsor ID
- 40093-201
- Keywords
- Refractory Hodgkin lymphoma, Relapsed Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCB040093 Monotherapy | Experimental | Drug: INCB040093 MonotherapyINCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. |
| INCB040093 and itacitinib (INCB039110) Combination Therapy | Experimental | Drug: INCB040093, Drug: itacitinibSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB040093 MonotherapyINCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. | Drug | INCB040093 Monotherapy |
| INCB040093INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food. | Drug | INCB040093 and itacitinib (INCB039110) Combination Therapy |
| itacitinibAlso: INCB039110The dose of itacitinib will be given orally once daily (QD). | Drug | INCB040093 and itacitinib (INCB039110) Combination Therapy |
Primary outcome
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.
5 secondary outcomes
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]
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]
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
To evaluate the duration of response (DOR)
Time frame: Week 36 disease evaluation
To evaluate the progression-free survival (PFS)
Time frame: Week 36 disease evaluation
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Langmuir, MD study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB040093 Monotherapy, INCB040093 and itacitinib in people with Refractory Hodgkin Lymphoma and Recurrent Adult Hodgkin's Lymphoma, run by Incyte Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.