- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01039519
A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Planned:
- Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
- Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.
Analyzed:
- Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana Farber Cancer Institute
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University-Knight Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
- Fox Chase Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must be at least 18 years of age at the time of study entry
- Must have histologically confirmed metastatic and/or unresectable GIST
- Must have measurable disease on computed tomography or magnetic resonance imaging as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Must have documented failure (due to either progression or intolerance)of at least prior imatinib and sunitinib. Previous administration of other known heat shock protein 90 (Hsp90) inhibitors is permitted
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Must have acceptable laboratory values as defined in the protocol
Exclusion Criteria:
- Known central nervous system metastases
- Major surgery within 4 weeks prior to receiving STA-9090
- Use of any investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter prior to receiving STA-9090
- No treatment with chronic immunosuppressants
- Must have otherwise adequate health status as defined in the protocol
- Left ventricular ejection fraction (LVEF) < than or = 50% at baseline
- Baseline corrected QT interval (QTc) > 470 msec
- Pregnant or lactating females
Plan de estudios
¿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 |
---|---|
Experimental: ganetespib 200 mg/m^2
Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle).
Treatment continues until disease progression or unacceptable toxicity.
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Ganetespib 200 mg/m^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week.
Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
Periodo de tiempo: Week 16 up to Week 47
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Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.
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Week 16 up to Week 47
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
Periodo de tiempo: Week 16 up to Week 47
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Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.
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Week 16 up to Week 47
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Kaplan-Meier Estimate of Progression Free Survival (PFS)
Periodo de tiempo: Day 1 up to Week 47
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PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as
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Day 1 up to Week 47
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Kaplan-Meier Estimate of Overall Survival
Periodo de tiempo: Day 1 up to week 97
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Overall survival was defined as the time from first dose to death or the date last known alive.
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Day 1 up to week 97
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Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
Periodo de tiempo: Day 2 to Day 10
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PET imaging was completed on selected patients only from one investigative site.
Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10.
PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999].
Tumor response was considered a complete response (CR) or a partial response (PR).
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Day 2 to Day 10
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Count of Participants With Treatment-Emergent Adverse Events (AEs)
Periodo de tiempo: Day 1 up to Week 51
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Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event. Dose modification includes dose delay and dose reduction. |
Day 1 up to Week 51
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 9090-05
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 Tumor del estroma gastrointestinal
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Hospital Universitario Virgen de la ArrixacaAún no reclutandoEnfermedades del HIGADO | Trasplante de hígado | Neoplasias Hepaticas | Tumores del estroma gastrointestinal | Metástasis | Metástasis hepáticas | Trasplante de hígado; Complicaciones | Cáncer de hígado | Trastorno de trasplante de hígado | Carcinoma de hígado | GIST maligno | ESENCIA | Metástasis | Cáncer de hígado... y otras condicionesEspaña
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National Cancer Institute (NCI)TerminadoTumor carcinoide gastrointestinal metastásico | Tumor carcinoide gastrointestinal recidivante | Tumor carcinoide gastrointestinal regionalEstados Unidos
-
Seoul National University HospitalReclutamientoTumor submucoso del tracto gastrointestinalCorea, república de
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National Cheng-Kung University HospitalNational Cheng Kung University; National Research Program for Biopharmaceuticals... y otros colaboradoresTerminadoTumor submucoso del tracto gastrointestinalTaiwán
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National Cancer Institute (NCI)Activo, no reclutandoTumor del estroma gastrointestinal metastásico | Sarcoma metastásico | Sarcoma localmente avanzado | Tumor del estroma gastrointestinal localmente avanzado | Tumor del estroma gastrointestinal gástrico y omental en estadio III AJCC v8 | Tumor del estroma gastrointestinal del intestino delgado... y otras condicionesEstados Unidos
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Centre Leon BerardReclutamientoTumor del estroma gastrointestinal metastásico | Tumor del estroma gastrointestinal irresecable (GIST) | Tumor del estroma gastrointestinal localmente avanzado (GIST)Francia
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Centre Leon BerardReclutamientoMutación C-KIT | Tumor metastásico del estroma gastrointestinal (GIST) | Tumor del estroma gastrointestinal avanzado (GIST)Francia
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Orlando Health, Inc.ReclutamientoCancer de pancreas | Cáncer de las vías biliares | Enfermedades de las vías biliares | Cáncer gastrointestinal | Enfermedad de los ganglios linfáticos | Quiste pancreático | Enfermedad pancreática | Tumor Gastrointestinal | Tumor submucoso del tracto gastrointestinalEstados Unidos
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National Cancer Institute (NCI)TerminadoGastrinoma | Glucagonoma | Insulinoma | Tumor carcinoide gastrointestinal metastásico | Tumor de polipéptido pancreático | Tumor carcinoide gastrointestinal recidivante | Carcinoma de células de los islotes recidivante | Somatostatinoma | Tumor carcinoide gastrointestinal regional | Tumor carcinoide pulmonarEstados Unidos
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Ascentage Pharma Group Inc.HealthQuest Pharma Inc.ReclutamientoTumor Sólido, Adulto | Tumor del estroma gastrointestinal (GIST)Porcelana
Ensayos clínicos sobre Ganetespib
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Synta Pharmaceuticals Corp.TerminadoCáncer de pulmón de células no pequeñasEstados Unidos, Canadá
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Emory UniversitySynta Pharmaceuticals Corp.TerminadoCáncer de rectoEstados Unidos
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University College, LondonCancer Research UKTerminadoCáncer de pulmón - Mesotelioma pleural malignoReino Unido
-
University of WashingtonNational Institute of Mental Health (NIMH)TerminadoTrastorno de ansiedad generalizada | Desorden de ansiedad social | Trastorno de pánico | Trastorno de estrés postraumáticoEstados Unidos
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Brigham and... y otros colaboradoresTerminado
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Synta Pharmaceuticals Corp.TerminadoCáncer de mama | Cáncer de mama triple negativo | Cáncer de mama HER-2 positivo | RE/Respuesta Progresiva (PR) + Refractario a Tratamiento Hormonal PrevioEspaña, Estados Unidos, Argentina, Bélgica, Brasil, Corea, república de, Perú, Reino Unido
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Synta Pharmaceuticals Corp.TerminadoLeucemia mieloide aguda | Leucemia linfoblástica aguda | LMA | LMC | TODOS | Leucemia mielógena crónica en fase blásticaEstados Unidos
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Synta Pharmaceuticals Corp.TerminadoTrastornos mieloproliferativos | LMA | SMD | LMCEstados Unidos
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UCB Biopharma S.P.R.L.TerminadoConvulsiones de inicio focal | Epilepsia resistente a los medicamentosEstados Unidos, Australia, Bélgica, Bulgaria, Canadá, Chequia, Francia, Alemania, Hungría, Italia, Japón, Lituania, México, Polonia, Portugal, Eslovaquia, España, Pavo, Reino Unido
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David M. Jackman, MDMassachusetts General Hospital; Beth Israel Deaconess Medical Center; Synta Pharmaceuticals...TerminadoCáncer de pulmón de células pequeñasEstados Unidos