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Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer

10 de octubre de 2017 actualizado por: Tarix Pharmaceuticals

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

This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin prescribed to women for the treatment of ovarian cancer. This experimental drug is called TXA127 and is being tested for effectiveness to see if it will help reduce some of the side effects of the chemotherapy, primarily low blood platelet levels that lead to excess bleeding. This study also intends to test the safety of TXA127 when given as an injection under the skin on a daily basis concurrently with up to 6 cycles of the prescribed chemotherapy.

Descripción general del estudio

Estado

Terminado

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

Intervencionista

Inscripción (Actual)

34

Fase

  • Fase 2

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

    • Alabama
      • Mobile, Alabama, Estados Unidos, 36604
        • University of Southern Alabama Mitchell Cancer Institute
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • USC - LAC Medical Center
      • Orange, California, Estados Unidos, 92868
        • University of California - Irvine, Chao Family Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush University Medical Center
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67208
        • Associates in Women's Health
    • New York
      • Brightwaters, New York, Estados Unidos, 11718
        • Schwartz Gynecologic Oncology, PLLC

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

Femenino

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

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: 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
Once daily subcutaneous injection of placebo
Experimental: TXA127 100 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 100 ug/kg/day TXA127
Once daily subcutaneous injection of 100 ug/kg
Otros nombres:
  • Angiotensina 1-7
Once daily subcutaneous injection of 300 ug/kg
Otros nombres:
  • Angiotensina 1-7
Experimental: TXA127 300 ug/kg
Combination gemcitabine and platinum-based chemotherapy with concurrent 300 ug/kg/day TXA127
Once daily subcutaneous injection of 100 ug/kg
Otros nombres:
  • Angiotensina 1-7
Once daily subcutaneous injection of 300 ug/kg
Otros nombres:
  • Angiotensina 1-7

¿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
Mean percentage of cycles with platelet counts below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles

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
Number of subjects who experienced a platelet count below 50,000/mm3
During a maximum of six 3-week chemotherapy cycles
Treatment Cycles With Platelets Counts Below 25,000/mm3
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Mean percentage of treatment cycles where platelets counts were below 25,000/mm3
During a maximum of six 3-week chemotherapy cycles
Chemotherapy Dose Intensity and Dose Density
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Mean percentage of cycles where projected (target) chemotherapy dose was maintained
During a maximum of six 3-week chemotherapy cycles
Lymphopenia as Determined by Lymphocyte Count
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of lymphopenia
During a maximum of six 3-week chemotherapy cycles
Neutropenia
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of neutropenia
During a maximum of six 3-week chemotherapy cycles
Anemia
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of anemia
During a maximum of six 3-week chemotherapy cycles
Mucositis
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of mucositis
During a maximum of six 3-week chemotherapy cycles
Alopecia
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles
Number of subjects with a treatment emergent adverse event of alopecia
During a maximum of six 3-week chemotherapy cycles
Rescue Treatment for Hematopoiesis and Mucositis
Periodo de tiempo: During a maximum of six 3-week chemotherapy cycles

Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:

  1. Transfusions
  2. Filgrastim or Pegfilgrastim
  3. Erythropoietin
  4. Palifermin
During a maximum of six 3-week chemotherapy cycles

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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.

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 octubre de 2008

Finalización primaria (Actual)

1 de diciembre de 2011

Finalización del estudio (Actual)

1 de diciembre de 2011

Fechas de registro del estudio

Enviado por primera vez

9 de octubre de 2008

Primero enviado que cumplió con los criterios de control de calidad

9 de octubre de 2008

Publicado por primera vez (Estimar)

13 de octubre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

10 de octubre de 2017

Última verificación

1 de octubre de 2017

Más información

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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