- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00513071
AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC).
II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530.
III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope
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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 prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:
- No prior chemotherapy and relatively minimal cancer spread
- Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease
Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):
- Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
- Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans)
Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug
- Measurable disease is not required but is allowed
Must be surgically or medically castrated
- If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
- Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months prior to registration
- ECOG performance status 0-2
- WBC >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Hemoglobin > 9 g/d
- Total bilirubin within normal institutional limits
- AST/ALT =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
- Must agree to use adequate contraception prior to study entry and for the duration of study participation
- At least 3 weeks since the completion of chemotherapy and radiotherapy and the patient must have recovered from the side effects of the therapy
- At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and demonstrated progression of disease since the agents were suspended
- Concurrent bisphosphonate therapy is allowed
Exclusion Criteria:
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets
- Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Use of specifically prohibited CYP3A4-active agents or substances
- Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
- Patients receiving any other investigational agents
- No investigational or commercial agents or therapies other than study drugs may be administered with the intent to treat the patient's malignancy
- HIV-positive patients on combination antiretroviral 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: Treatment (saracatinib)
Patients receive oral AZD0530 once daily.
Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
|
Estudios correlativos
Administrado oralmente
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
PSA Response Rate
Periodo de tiempo: PSA measured every 4 weeks
|
Complete Response (CR), disappearance of all measurable and non-measurable disease.
No new lesions.
PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR
|
PSA measured every 4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression-free Survival (PFS)
Periodo de tiempo: From start of treatment until progression or death, up to 2 years
|
PFS defined as time between start of treatment and disease progression or death.
Using the method of Kaplan-Meier.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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.
|
From start of treatment until progression or death, up to 2 years
|
Time to Treatment Failure
Periodo de tiempo: From first day of treatment until discontinuation of treatment, up to 2 years
|
Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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
|
From first day of treatment until discontinuation of treatment, up to 2 years
|
Overall Survival
Periodo de tiempo: From start of treatment, up to 5 years
|
Estimated using the product-limit method of Kaplan and Meier.
|
From start of treatment, up to 5 years
|
Toxicity Data
Periodo de tiempo: Up to 2 years
|
Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.
|
Up to 2 years
|
Relationship Between Changes in Laboratory Correlates and Response and Survival
Periodo de tiempo: Up to 2 years
|
Up to 2 years
|
|
N-telopeptide and Deoxypyridinoline as Prognostic Bone Markers
Periodo de tiempo: At baseline, at 6 hours, at each course (day 1), and at 2 years
|
At baseline, at 6 hours, at each course (day 1), and at 2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Primo Lara, City of Hope Medical Center
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCI-2012-02842
- N01CM62201 (Subvención/contrato del NIH de EE. UU.)
- PHII-79
- N01CM62209 (Subvención/contrato del NIH de EE. UU.)
- CDR0000559142 (Identificador de registro: PDQ (Physician Data Query))
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.
producto fabricado y exportado desde los 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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