Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

6 de abril de 2020 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

83

Fase

  • Fase 2
  • Fase 1

Acceso ampliado

Ya no está disponible fuera del ensayo clínico. Ver registro de acceso ampliado.

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Experimental: 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.
Otros nombres:
  • Gemzar®
Droga: nab-paclitaxel
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
Otros nombres:
  • 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.
Otros nombres:
  • Kyprolis®
Droga: bortezomib
Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
Otros nombres:
  • Velcade®
Droga: lenalidomide
Lenalidomide administered orally at the protocol-specified dose and frequency.
Otros nombres:
  • Revlimid®
Droga: azacitidine
Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
Otros nombres:
  • Vidaza®
Droga: pomalidomide
Pomalidomide administered orally at the protocol-specified dose and frequency.
Otros nombres:
  • Pomalyst®
Droga: INCB050465
INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
Experimental: 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.
Otros nombres:
  • Vidaza®
Droga: INCB039110
INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
Otros nombres:
  • itacitinib

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Incyte Corporation

Investigadores

  • Director de estudio: Ekaterine Asatiani, M.D., Incyte Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de septiembre de 2014

Finalización primaria (Actual)

27 de febrero de 2019

Finalización del estudio (Actual)

27 de febrero de 2019

Fechas de registro del estudio

Enviado por primera vez

29 de septiembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

10 de octubre de 2014

Publicado por primera vez (Estimar)

16 de octubre de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de abril de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

6 de abril de 2020

Última verificación

1 de abril de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • INCB 52793-101

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Cáncer metastásico

Ensayos clínicos sobre INCB052793

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Denmark

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir