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Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer

24 de noviembre de 2020 actualizado por: Eli Lilly and Company

A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma

The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

28

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

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19103
        • Gynecologic Oncology Group 215-854-0770

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:

  • Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
  • All participants must have measurable disease.
  • Participants must have at least one "target lesion" to be used to assess response on this protocol.
  • Participants must not be eligible for a higher priority GOG protocol, if one exists.
  • Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
  • Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
  • Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
  • Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.

Exclusion Criteria:

  • Participants with previous enzastaurin treatment.
  • Participants who have received radiation to more than 25% of marrow-bearing areas
  • Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
  • Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
  • Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
  • Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
  • Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.

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 Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: A
1125 mg loading dose then 500 mg, oral, daily, until progressive disease
Otros nombres:
  • LY317615

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival for at Least 6 Months (PFS-6)
Periodo de tiempo: Baseline through 6 months
Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Baseline through 6 months
Number of Participants With Adverse Events and Severe Adverse Events
Periodo de tiempo: Baseline through end of study (Up to 45 months)
Data presented are the number of participants who experienced 1 or more adverse events (AEs) (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Baseline through end of study (Up to 45 months)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Duration of Progression-Free Survival
Periodo de tiempo: Baseline to disease progression (Up to 38 months)
PFS is defined as the rate of PFS from the date of diagnosis to the first date of objectively determined progressive disease (based on radiological assessment) or death from any cause. It is assumed that PFS follows an exponential distribution.
Baseline to disease progression (Up to 38 months)
Prognostic Factors: Platinum Sensitivity
Periodo de tiempo: Baseline
Participants who had disease progression within 6 months of ending their last regimen of platinum therapy were considered platinum resistant. Participants who had disease progression between 6 and 12 months of ending their last platinum regimen were considered platinum sensitive. Participants who had disease progression beyond 12 months of ending their last platinum regimen were also considered platinum sensitive.
Baseline
Prognostic Factors: Performance Status
Periodo de tiempo: Baseline
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
Baseline
Overall Survival
Periodo de tiempo: Baseline through end of study (Up to 45 months)
Overall survival (OS) time is defined as the time from the date of diagnosis to the date of death from any cause. For participants who are still alive at the time of analysis, survival time will be censored at the last contact date.
Baseline through end of study (Up to 45 months)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Director de estudio: Lydia Usha, Gynecologic Oncology Group

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 enero de 2007

Finalización primaria (Actual)

1 de mayo de 2008

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

8 de enero de 2007

Primero enviado que cumplió con los criterios de control de calidad

8 de enero de 2007

Publicado por primera vez (Estimar)

11 de enero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de diciembre de 2020

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

24 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 10738
  • H6Q-MC-S025 (Otro identificador: Eli Lilly and Company)

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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