A Phase 1-2, XIAP Antisense AEG35156 With Weekly Paclitaxel in Patients With Advanced Breast Cancer
30 de noviembre de 2009 actualizado por: Aegera Therapeutics
A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer
This is an open-label multicenter, phase 1-2 study.
Following determination of the recommended AEG35156 dose in combination with weekly paclitaxel in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination in advanced breast cancer.
Descripción general del estudio
Descripción detallada
Breast cancer is the most common cancer in women in the United States, the second most common cause of cancer death, and the main cause of death in women ages 45 to 55.
In 2006, 212,920 American women will be diagnosed with breast cancer, and 40,970 will die from this disease.[1].
Fewer than 10 percent of women present with metastatic disease at the time of diagnosis.
However, the majority of women who relapse after initial definitive therapy for early stage or locally advanced disease will do so with disseminated metastatic disease rather than an isolated local recurrence.
Treatment for metastatic disease is palliative in intent and will usually involve hormone therapy and/or chemotherapy with or without trastuzumab.
Active chemotherapy agents include anthracyclines, taxanes, vinorelbine, alkylating agents and antimetabolites.
Taxanes have become the cornerstone of first-line treatment for metastatic breast cancer.
Weekly doses of paclitaxel can be administered continuously for several weeks with a remarkable lack of myelosuppression [2].
Weekly paclitaxel (80 mg/m2) was directly compared to every three-week therapy (175 mg/m2) in 585 women with metastatic breast cancer.
Weekly therapy was associated with a significantly higher response rate (40 versus 28 percent) and longer TTP (nine versus five months), but similar overall survival and worse neurotoxicity [3].
Since patients with metastatic breast cancer are unlikely to be cured of their disease [4], they should be considered candidates for a clinical trial.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
61
Fase
- Fase 2
- 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
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80218
- Rocky Mountain Cancer Center
-
-
Florida
-
Ocoee, Florida, Estados Unidos, 34761
- Cancer Centers of Florida, P.A.
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46219
- Central Indiana Cancer Center
-
-
New York
-
Albany, New York, Estados Unidos, 12206
- New York Oncology & Hematology P. C., Albany Cancer Center
-
-
Ohio
-
Dayton, Ohio, Estados Unidos, 45409
- Dayton Oncology & Hematology, P.A.
-
-
South Carolina
-
Greenville, South Carolina, Estados Unidos, 29605
- Cancer Centers of the Carolinas
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75246
- Sammons Cancer Center
-
Tyler, Texas, Estados Unidos, 75702
- Tyler Cancer Center
-
-
Virginia
-
Norfolk, Virginia, Estados Unidos, 23502
- Virginia Oncology Associates
-
-
Washington
-
Vancouver, Washington, Estados Unidos, 98684
- Northwest Cancer Specialists, P. C.
-
-
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:
- Patients with histologically or cytologically confirmed breast adenocarcinoma who are candidates for paclitaxel single agent chemotherapy for metastatic breast cancer
- ECOG performance < 2
- One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
- Life expectancy of at least 6 months
- Age > 18 years
- Signed, written IRB-approved informed consent
- A negative serum pregnancy test (if applicable)
- Acceptable liver function:
- Bilirubin within normal limit
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 2.0 times the institution's upper limit of normal
- Acceptable renal function:
- Serum creatinine within normal limits, OR calculated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Acceptable hematologic status:
- Granulocyte > 1500 cells/uL
- Platelet count > 100,000 plt/uL
- Hemoglobin > 9.0 g/dL
- Acceptable coagulation status:
- PT within normal limits
- PTT within normal limits
- For women of child-bearing potential, the use of effective contraceptive methods during the study
- Prior radiotherapy is allowed provided disease progression outside the radiation field has been documented, and treatment completed at least 2 weeks prior to registration
Exclusion Criteria:
- Prior taxane chemotherapy for metastatic disease.
- More than one prior chemotherapy regimen for metastatic disease
- Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions
- Grade > 2 peripheral neuropathy
- Known bleeding diathesis or concurrent treatment with anticoagulants except patients on non-therapeutic line maintenance coumadin
- Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Known infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Patients who are currently receiving any other investigational agent. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
- Unwillingness or inability to comply with procedures required in this protocol
- Any deviation from these inclusion/exclusion criteria must be discussed with the sponsor prior to enrolling patient.
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)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
To determine the recommended dose of AEG35156 when used in combination with weekly paclitaxel and at the dose enhance the clinical benefit rate (CBR) of paclitaxel in patients with advanced breast cancer.
Periodo de tiempo: 2 years
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Determinar la supervivencia libre de progresión.
Periodo de tiempo: 2 años
|
2 años
|
|
To establish the pharmacokinetics of AEG35156 and paclitaxel when used in combination.
Periodo de tiempo: 2 years
|
2 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Jacques Jolivet, MD, FACP, Aegera Therapeutics, Inc.
- Investigador principal: David M Loesch, MD, Central Indiana Cancer Centers
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
- Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.
- Greenberg PA, Hortobagyi GN, Smith TL, Ziegler LD, Frye DK, Buzdar AU. Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer. J Clin Oncol. 1996 Aug;14(8):2197-205. doi: 10.1200/JCO.1996.14.8.2197.
- Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001 Nov 15;19(22):4216-23. doi: 10.1200/JCO.2001.19.22.4216.
- Seidman, A., et al., CALGB 9840: Phase III study of weekly paclitaxel via 1-hour infusion versus standard 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. Proc Am Soc Clin Oncol, 2004. 23: p. 6s.
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
1 de noviembre de 2007
Finalización primaria (Actual)
1 de mayo de 2009
Finalización del estudio (Actual)
1 de mayo de 2009
Fechas de registro del estudio
Enviado por primera vez
13 de noviembre de 2007
Primero enviado que cumplió con los criterios de control de calidad
13 de noviembre de 2007
Publicado por primera vez (Estimar)
15 de noviembre de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de diciembre de 2009
Última actualización enviada que cumplió con los criterios de control de calidad
30 de noviembre de 2009
Última verificación
1 de noviembre de 2009
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AEG35156-202
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. .