Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma
19 de junio de 2019 actualizado por: Millennium Pharmaceuticals, Inc.
An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The drug being tested in this study is ixazomib. Ixazomib is being tested to treat people who have multiple myeloma. This study will look at the safety and efficacy of ixazomib and will enroll approximately 60 participants.
Participants will receive ixazomib by oral capsule twice weekly on Days 1, 4, 8, and 11 of a 21-day cycle. The study will consist of a dose escalation phase to determine the MTD, followed by an expansion phase in which participants will be treated at the MTD.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 8 years.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- Fase 1
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
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Florida
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Tampa, Florida, Estados Unidos, 33617
- H. Lee Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Comprehensive Cancer Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- M.D. Anderson Cancer Center
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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:
Each participant must meet all of the following inclusion criteria to be enrolled in the study:
- Multiple myeloma diagnosed according to the standard criteria.
- Participants with multiple myeloma who have relapsed following at least 2 lines of therapy.
- Participants must have measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
- Voluntary written consent.
- Suitable venous access for study-required blood sampling.
Exclusion Criteria:
Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- Peripheral neuropathy greater than or equal to (>=) Grade 2.
- Female participants who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 14 days before the first dose of study drug.
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment.
- Life-threatening illness unrelated to cancer.
- Diarrhea > Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.
- Systemic antineoplastic or radiation therapy within 14 days of cytotoxic agents within 21 days before the first dose of study treatment.
- Treatment with any investigational products within 21 days before the first dose of study treatment.
- Treatment with any investigational proteasome inhibitor.
- Systemic treatment with prohibited medication.
- Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day. Inhaled and topical steroids are permitted.
- Central nervous system involvement.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
- Corrected QT interval (QTc) > 470 milliseconds on a 12-lead electrocardiogram (ECG) obtained during the screening period.
- Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of ixazomib including difficulty swallowing.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2
Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
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Cápsulas de ixazomib
Otros nombres:
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Experimental: Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months.
Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
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Cápsulas de ixazomib
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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An AE is any untoward medical occurrence in a participant 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, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.
A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
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From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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Number of Participants With Clinically Significant Abnormalities Reported as TEAEs
Periodo de tiempo: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs.
Parameters assessed were hematology, serum chemistry and urinalysis.
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From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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Number of Participants With a TEAE of Peripheral Neuropathy
Periodo de tiempo: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.
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From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
Periodo de tiempo: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs.
Measurement of vital signs, included oral temperature, blood pressure, and heart rate.
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From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
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Maximum Tolerated Dose (MTD) of Ixazomib
Periodo de tiempo: Cycle 1 (21 days)
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MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation.
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Cycle 1 (21 days)
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Recommended Phase 2 Dose (RP2D) of Ixazomib
Periodo de tiempo: Cycle 1 through Cycle 39 (Up to 28.3 months)
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The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.
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Cycle 1 through Cycle 39 (Up to 28.3 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cmax: Maximum Observed Plasma Concentration for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
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Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
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Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
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λz: Terminal Disposition Phase Rate Constant for Ixazomib
Periodo de tiempo: Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose
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Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose
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T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib
Periodo de tiempo: Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose
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Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose
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CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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CL/F is apparent clearance of the drug from the plasma.
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Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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Emax: Maximum Observed Effect for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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Emax was determined to characterize the whole blood 20S proteasome inhibition parameters.
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Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib
Periodo de tiempo: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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TEmax was determined to characterize the whole blood 20S proteasome inhibition parameters.
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Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
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Overall Response Rate (ORR)
Periodo de tiempo: Cycle 1 through Cycle 115 (Up to 80.1 months)
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ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria.
CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg /24 h.
MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions.
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Cycle 1 through Cycle 115 (Up to 80.1 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.
- Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014 Aug 14;124(7):1038-46. doi: 10.1182/blood-2014-01-548826. Epub 2014 Jun 11.
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)
12 de octubre de 2009
Finalización primaria (Actual)
20 de junio de 2013
Finalización del estudio (Actual)
23 de mayo de 2017
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2009
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2009
Publicado por primera vez (Estimar)
3 de julio de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteasa
- Ixazomib
Otros números de identificación del estudio
- C16003
- U1111-1177-7936 (Identificador de registro: WHO)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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. .
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