- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00771810
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
Ph IIb Study Evaluating the Safety & Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study comparing safety and efficacy of two dose levels of TXA127 when administered during 6 cycles of combination gemcitabine and platinum-based chemotherapy. This study intends to investigate the effectiveness of TXA127 for the mitigation of severity and/or incidence of thrombocytopenia, as well as safety when administered as a self-injected, subcutaneous solution.
Females 18 years of age or older with a confirmed diagnosis of ovarian carcinoma who are scheduled to undergo combination chemotherapy with gemcitabine and carboplatin or gemcitabine and cisplatin will be considered for this study. Subjects may be chemotherapy naïve, newly diagnosed, or post a single course of chemotherapy followed by a progression- and treatment-free interval of at least 3 months, or post 2 or more previous courses of chemotherapy after a progression- and treatment-free interval of at least 6 months.
Subjects will be randomized in a 1:1:1 ratio to one of the following three blinded treatment groups: placebo, 100 ug/kg/day TXA127 and 300 ug/kg/day TXA127.
Treatment will be concurrent with up to six consecutive 21-day cycles of one of the following gemcitabine and platin regimens:
Regimen A
- Intravenous cisplatin therapy at a dose of 30-50 mg/m2 given on Day 1 of the cycle
- Intravenous gemcitabine at a dose of 800 mg/m2 given on Day 1 after cisplatin and on Day 8 of the cycle.
Regimen B
- Intravenous gemcitabine at a dose of 1000 mg/m2 given on Days 1 and 8 of the cycle
- Intravenous carboplatin AUC 4 given after gemcitabine on Day 1 of the cycle
TXA127 will be self-administered as a subcutaneous injection by the subject once daily on Days 2-6 and 9-15 during each cycle of chemotherapy. Blood specimens will be drawn for hematologic analysis on Days 1, 8 and 15 of each treatment cycle.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Mobile, Alabama, Estados Unidos, 36604
- University of Southern Alabama Mitchell Cancer Institute
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California
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Los Angeles, California, Estados Unidos, 90033
- USC - LAC Medical Center
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Orange, California, Estados Unidos, 92868
- University of California - Irvine, Chao Family Comprehensive Cancer Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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Kansas
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Wichita, Kansas, Estados Unidos, 67208
- Associates in Women's Health
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New York
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Brightwaters, New York, Estados Unidos, 11718
- Schwartz Gynecologic Oncology, PLLC
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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:
Females at least 18 years of age with ovarian carcinoma who are one of the following:
- Newly diagnosed with ovarian cancer and chemotherapy naïve, or
- Post a single previous course of chemotherapy, with a 3-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit, or
- Post two or more previous courses of chemotherapy with a 6-month disease-progression and treatment-free interval, with the exception of antibody therapy, prior to the study screening visit.
- Must be scheduled for a course of combination chemotherapy consisting of gemcitabine and cisplatin or gemcitabine and carboplatin to be administered in 21-day cycles
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate bone marrow, renal, and hepatic functions as measured by standard chemistry and hematology blood tests
- Adequate blood coagulation parameters as measured by standard blood tests for coagulation
Exclusion Criteria:
- Any clinical or laboratory abnormality greater than Grade 2 toxicity (NCI criteria), with the exception of laboratory parameters specified in the inclusion criteria
- Significant unstable cardiovascular disease
- Uncontrolled high blood pressure
- Current use of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II antagonists
- Evidence of metastatic disease to the bone
- Metastatic disease to the CNS requiring treatment or radiation therapy
- Uncontrolled infection(s)
- Radiation therapy or chemotherapy (except as specified in the inclusion criteria) within the previous 5 years
- Concurrent use of hematopoietic or erythropoietic agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Placebo
Combination gemcitabine and platinum-based chemotherapy with concurrent placebo
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Once daily subcutaneous injection of placebo
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Experimental: TXA127 100 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
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Once daily subcutaneous injection of 100 ug/kg
Otros nombres:
Once daily subcutaneous injection of 300 ug/kg
Otros nombres:
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Experimental: TXA127 300 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
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Once daily subcutaneous injection of 100 ug/kg
Otros nombres:
Once daily subcutaneous injection of 300 ug/kg
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Mean percentage of cycles with platelet counts below 50,000/mm3
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During a maximum of six 3-week chemotherapy cycles
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Subjects With Platelet Counts Below 50,000/mm3
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects who experienced a platelet count below 50,000/mm3
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During a maximum of six 3-week chemotherapy cycles
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Treatment Cycles With Platelets Counts Below 25,000/mm3
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
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During a maximum of six 3-week chemotherapy cycles
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Chemotherapy Dose Intensity and Dose Density
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Mean percentage of cycles where projected (target) chemotherapy dose was maintained
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During a maximum of six 3-week chemotherapy cycles
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Lymphopenia as Determined by Lymphocyte Count
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of lymphopenia
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During a maximum of six 3-week chemotherapy cycles
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Neutropenia
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of neutropenia
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During a maximum of six 3-week chemotherapy cycles
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Anemia
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of anemia
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During a maximum of six 3-week chemotherapy cycles
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Mucositis
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of mucositis
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During a maximum of six 3-week chemotherapy cycles
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Alopecia
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of alopecia
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During a maximum of six 3-week chemotherapy cycles
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Rescue Treatment for Hematopoiesis and Mucositis
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
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Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:
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During a maximum of six 3-week chemotherapy cycles
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Rodgers KE, Oliver J, diZerega GS. Phase I/II dose escalation study of angiotensin 1-7 [A(1-7)] administered before and after chemotherapy in patients with newly diagnosed breast cancer. Cancer Chemother Pharmacol. 2006 May;57(5):559-68. doi: 10.1007/s00280-005-0078-4. Epub 2005 Aug 12.
- Ellefson DD, diZerega GS, Espinoza T, Roda N, Maldonado S, Rodgers KE. Synergistic effects of co-administration of angiotensin 1-7 and Neupogen on hematopoietic recovery in mice. Cancer Chemother Pharmacol. 2004 Jan;53(1):15-24. doi: 10.1007/s00280-003-0710-0. Epub 2003 Oct 16.
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
Palabras clave
Términos MeSH relevantes adicionales
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Enfermedades hematológicas
- Trastornos de las plaquetas sanguíneas
- Agranulocitosis
- Leucopenia
- Trastornos de los leucocitos
- Neutropenia
- Trombocitopenia
- Linfopenia
- Agentes antihipertensivos
- Agentes vasodilatadores
- Angiotensina I (1-7)
Otros números de identificación del estudio
- TXA127-2007-002
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