- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02060370
Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
A Phase II Study of Alternative Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma (mRCC)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take sunitinib capsules by mouth every day for 2 weeks, followed by 1 week in which you do not receive any study drug. This will then be repeated every 3 weeks.
Every 6 weeks will be 1 study cycle.
If you have any side effects tell the study doctor right away. The study doctor may change your dose of the study drug.
Study Visits:
Every day during the first week, and then at least 1 time each week during the study, your blood pressure will be checked (either at home, at the clinic, or by your local doctor). You will need to write down your blood pressure in a blood pressure diary each time you check it and bring the diary with you to each clinic visit.
On Day 1 of Cycle 1:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
- You will fill out a questionnaire about the quality of your life and about how you are feeling. This should take about 5 minutes.
On Day 42 of every cycle:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests.
On Day 42 of every even-numbered cycle (Cycles 2, 4, 6, and so on):
- You will have a CT scan of your chest, abdomen, and pelvis.
- Blood (about 1 tablespoon) will be drawn to check your thyroid function.
- Blood (about 2 tablespoons) will be drawn for biomarker testing. (Cycles 2 , 4, and 6 only)
- You will fill out the questionnaire about the quality of your life and about how you are feeling. (Cycles 2 , 4, and 6 only)
At any time that the doctor thinks it is needed, additional blood (about 1 tablespoon) may be drawn to check your thyroid function, and you may need to have a bone scan and CT scan or MRI of the brain to check the status of the disease.
Length of Study:
You may continue taking the study drug for as long as the study doctor thinks it is in your best interest. You will be taken off treatment if the disease gets worse, intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after the follow-up visit. However, the study team may perform a medical record review or follow-up call to check on how you are doing. If you are called, this should last about 5-10 minutes.
End-of-Treatment Visit:
After you are no longer receiving the study drug, you will have an end-of-treatment visit. You will have a physical exam and blood (about 3-4 tablespoons) will be drawn for routine and biomarker testing.
End-of- Treatment Follow-Up Visit:
About 30 days after your end-of-treatment visit you will have a follow-up visit and the following procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests.
- You will have CT scans of your chest, abdomen and pelvis to check the status of the disease.
This is an investigational study. Sunitinib is FDA approved and commercially available to treat advanced kidney cancer. The dosing schedule being used on this study is investigational.
Up to 60 participants will be enrolled in this study. Up to 60 may take part at MD Anderson.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University Medical Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- Lineberger Cancer Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig 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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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson 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:
- Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology. Prior nephrectomy is not a requirement for eligibility
- Age >/=18 years
- Measurable or evaluable metastatic disease per RECIST v 1
- ECOG performance status 0-1
- Normal organ and bone marrow function as defined by: Serum aspartate transaminase (AST) or serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) </= 2.5 x laboratory upper limit of normal (ULN); Total serum bilirubin </= 2.0 x ULN; Absolute neutrophil count (ANC) >/= 1500/µL; Platelets >/= 100,000/µL; Hemoglobin >/= 9.0 g/dL (transfusion permitted); Serum calcium </= 12.0 mg/dL; Serum creatinine </= 2.5 mg/dL
- Patients with a history of deep venous thromboembolism or pulmonary embolism on treatment with anticoagulation are eligible for the study.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > 6 months prior to registration and therapy not discontinued for toxicity)
- Uncontrolled hypertension (defined as blood pressure >140/90 mm Hg not controlled with anti-hypertensives)
- Prior intraabdominal, intrathoracic, vascular, spinal or intracranial surgery or radiation therapy within 4 weeks of starting treatment
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Current treatment on another therapeutic clinical trial
- Any of the following within the preceding 6 months- myocardial infarction, severe/unstable angina, severe peripheral vascular disease (claudication) or procedure on peripheral vasculature, coronary/peripheral artery bypass, graft, cerebrovascular accident or transient ischemic attack, clinically significant bleeding
- Pregnant or breastfeeding women are excluded from this study because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib. Breastfeeding must be discontinued if the mother is treated with sunitinib
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy
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: Sunitinib
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
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Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Otros nombres:
Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Rate of Toxicity
Periodo de tiempo: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
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Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea.
Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression-Free Survival (PFS)
Periodo de tiempo: 17 months
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Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
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17 months
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The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Periodo de tiempo: Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.
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Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4
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Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.
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Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
Periodo de tiempo: 2 years
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Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.
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2 years
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Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Periodo de tiempo: 36 weeks from the start of treatment
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Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36.
The score range is from 0 to 180 with higher scores reflecting a better quality of life.
The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity.
The total number of surveys changes as the weeks progress.
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36 weeks from the start of treatment
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Changes in Circulating DNA Levels With Antiangiogenic Treatment
Periodo de tiempo: Not applicable due data not generated due to timing and budgetary issues
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Not applicable due data not generated due to timing and budgetary issues
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias por sitio
- Enfermedades Renales
- Enfermedades urológicas
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Renales
- Carcinoma De Célula Renal
- Carcinoma
- Neoplasias urogenitales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la proteína quinasa
- Sunitinib
Otros números de identificación del estudio
- 2013-0944
- NCI-2014-01908 (Identificador de registro: NCI CTRP)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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