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An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

6 aprile 2020 aggiornato da: Incyte Corporation

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

83

Fase

  • Fase 2
  • Fase 1

Accesso esteso

Non più disponibile al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti
    • California
      • West Hollywood, California, Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti
    • Georgia
      • Atlanta, Georgia, Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti
    • Indiana
      • Indianapolis, Indiana, Stati Uniti
    • New Jersey
      • Hackensack, New Jersey, Stati Uniti
    • New York
      • New York, New York, Stati Uniti
    • North Carolina
      • Durham, North Carolina, Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti
    • South Carolina
      • Greenville, South Carolina, Stati Uniti
    • Tennessee
      • Nashville, Tennessee, Stati Uniti
      • Nashville, Tennessee, Stati Uniti
        • Site 2
    • Texas
      • Dallas, Texas, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Phase 1a

  • Aged 18 years or older
  • Histologically or cytologically confirmed solid tumor or hematologic malignancy
  • Life expectancy of 12 weeks or longer
  • Must have received ≥ 1 prior treatment regimen
  • Must not be a candidate for potentially curative or standard of care approved therapy

Phase 1b

  • Aged 18 years or older
  • Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion
  • Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease
  • Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome
  • Cohort H: Individuals diagnosed with lymphoma

  • Prior therapy:

    • Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
    • Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens
    • Cohort F: May have received any number of prior treatment regimens or be treatment-naïve
    • Cohort H: Must have relapsed from or have been refractory to available treatments

Phase 2

  • Aged 18 years or older
  • Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome

  • Prior therapy:

    • Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)

Exclusion Criteria:

  • Prior receipt of a JAK1 inhibitor (Phase 1a only)
  • Known active central nervous system metastases and/or carcinomatous meningitis
  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort)
  • Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Phase 1a: INCB052793 Monotherapy
Droga: INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
Droga: INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
Sperimentale: Phase 1b: INCB052793 Combination Therapy
Droga: INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
Droga: INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
Droga: gemcitabine
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
Altri nomi:
  • Gemzar®
Droga: nab-paclitaxel
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
Altri nomi:
  • Abraxane®
Droga: dexamethasone
Dexamethasone administered orally at the protocol-specified dose and frequency.
Droga: Carfilzomib
Carfilzomib administered intravenously at the protocol-specified dose and frequency.
Altri nomi:
  • Kyprolis®
Droga: bortezomib
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
Altri nomi:
  • Velcade®
Droga: lenalidomide
Lenalidomide administered orally at the protocol-specified dose and frequency.
Altri nomi:
  • Revlim®
Droga: azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
Altri nomi:
  • Vidaza®
Droga: pomalidomide
Pomalidomide administered orally at the protocol-specified dose and frequency.
Altri nomi:
  • Pomalist®
Droga: INCB050465
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
Sperimentale: Phase 2: INCB052793 and itacitinib Combination Therapy
Droga: INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
Droga: INCB052793
INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
Droga: azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
Altri nomi:
  • Vidaza®
Droga: INCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Altri nomi:
  • itacitinib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Lasso di tempo: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
Lasso di tempo: Baseline through end of study (Up to approximately 4.5 years)
ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
Baseline through end of study (Up to approximately 4.5 years)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
Lasso di tempo: Baseline through end of study (Up to approximately 4.5 years)
Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.
Baseline through end of study (Up to approximately 4.5 years)
Phase 2: Number of Participants With at Least One TEAE and SAE
Lasso di tempo: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Lasso di tempo: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Lasso di tempo: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
Lasso di tempo: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib
Lasso di tempo: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib
Lasso di tempo: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib
Lasso di tempo: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Lasso di tempo: Cycle 1, Day 1
Cmax is defined as the maximum observed plasma concentration measured at Day 1.
Cycle 1, Day 1
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Lasso di tempo: Cycle 1, Day 1
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 1, Day 1
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t
Lasso di tempo: Cycle 1, Day 1
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 1, Day 1
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Lasso di tempo: Cycle 1, Day 15
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Cycle 1, Day 15
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Lasso di tempo: Cycle 1, Day 15
Minimum observed plasma concentration measured at steady state (Day 15).
Cycle 1, Day 15
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Lasso di tempo: Cycle 1, Day 15
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 1, Day 15
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
Lasso di tempo: Cycle 1, Day 15
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Cycle 1, Day 15
Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
Lasso di tempo: Cycle 1, Day 15
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 1, Day 15
Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
Lasso di tempo: Cycle 2, Day 1
Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.
Cycle 2, Day 1
Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
Lasso di tempo: Cycle 2, Day 1
Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1
Cycle 2, Day 1
Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
Lasso di tempo: Cycle 2, Day 1
Tmax is the time to maximum (peak) observed plasma drug concentration.
Cycle 2, Day 1
Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
Lasso di tempo: Cycle 2, Day 1
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 2, Day 1
Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
Lasso di tempo: Cycle 2, Day 1
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Cycle 2, Day 1

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Incyte Corporation

Investigatori

  • Direttore dello studio: Ekaterine Asatiani, M.D., Incyte Corporation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 settembre 2014

Completamento primario (Effettivo)

27 febbraio 2019

Completamento dello studio (Effettivo)

27 febbraio 2019

Date di iscrizione allo studio

Primo inviato

29 settembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

10 ottobre 2014

Primo Inserito (Stima)

16 ottobre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • INCB 52793-101

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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