INCB040093 and INCB040093 Combined With Itacitinib (INCB039110) in Relapsed/Refractory Hodgkin Lymphoma
8. januar 2018 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
8
Fase
- Fase 2
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: INCB040093 Monotherapy
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
|
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
|
|
Eksperimentell: 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.
|
INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
The dose of itacitinib will be given orally once daily (QD).
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR) as determined by the percentage of subjects achieving a partial response (PR) or complete response (CR)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of participants reporting adverse events in the monotherapy group
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2015
Primær fullføring (Faktiske)
16. desember 2016
Studiet fullført (Faktiske)
16. desember 2016
Datoer for studieregistrering
Først innsendt
19. mars 2015
Først innsendt som oppfylte QC-kriteriene
27. mai 2015
Først lagt ut (Anslag)
28. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 40093-201
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