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- Ensayo clínico NCT01555242
A Study of Aneustat (OMN54) in Patients With Advanced Cancer and Lymphomas
7 de abril de 2015 actualizado por: Omnitura Therapeutics, Inc.
A Phase I, Open-Label, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Aneustat™ (OMN54) Administered on a Daily Oral Regimen in Patients With Advanced Cancer and Lymphomas
This is a phase I, open-label, multiple dose, dose escalation study to assess the safety, tolerability and pharmacokinetics of Aneustat™ (OMN54), a novel therapy, administered orally in patients with advanced cancer and lymphomas.
Descripción general del estudio
Descripción detallada
Patients who complete a 28-day cycle, may be eligible to continue receiving Aneustat™ (OMN54) in 4-week increments for up to 6 cycles (inclusive of cycle 1) if further treatment is judged to be of possible benefit; if patient has not experienced unacceptable toxicity; and no study withdrawal criteria has been met.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
Fase
- 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
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- BC Cancer Agency-Vancouver Centre
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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:
- Histological or cytological evidence of malignancy
- Male or female, 18 years or older
- Presence of advanced tumours, i.e., measurable or non-measurable disease (RECIST criteria, version 1.1)that have recurred or progressed following standard therapy
- Able to swallow the oral capsule form of the drug
- Failed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy.
Haematology within 7 days of Day 1 (initial dose):
- Hemoglobin (Hb) > 9.0 g/dL
- Platelets ≥ 100,000 cells/mm3 (or, ≥100 x 10/L)
- Absolute neutrophil count (ANC) > 1.5 cells x109/L (or, > 1500 cells/mm3)
Chemistry within 7 days of Day 1 (initial dose):
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN if no liver metastases, AST(SGOT)/ALT(SGPT) < 5 x ULN if liver metastases
- Bilirubin < 1.5 x ULN unless Gilbert's Syndrome
- Serum creatinine ≤ 1.25 ULN
Coagulation within 7 days of Day 1 (initial dose):
*INR ≤ 1.5
- ECOG Performance Status between 0 - 2 and estimated life expectancy of > 3 months.
- Having the initiative and means to be compliant with the protocol (as judged by the Principal Investigator) and is within a feasible geographical proximity of the study center to make the required study visits.
- Written informed consent obtained prior to any study screening procedures
- Females of childbearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus) must have a negative urine pregnancy test (UPT) within 7 days of Day 1 (initial dose)
- Females of childbearing potential must agree to use an effective method of contraception (i.e., sexual abstinence, condoms, intrauterine device, diaphragm) from Screening period and throughout study participation.
Exclusion Criteria:
- Patient has uncontrolled or symptomatic brain metastases (If a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days prior to Day 1 dosing).
- Use of an investigational medication or device within 30 days of initiating study therapy (Day 1).
- Major surgery within 30 days prior to first dose (Day 1).
- Radiotherapy, chemotherapy, or immunotherapy within 28 days prior to Day 1 (not including palliative radiotherapy at focal sites).
- Pregnancy or lactation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY Heart Association Class III or IV, see Appendix 3), unstable angina pectoris, unstable cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Screening (within approximately 28 days of registration) 12-lead electrocardiogram (ECG) that is abnormal and clinically significant
- Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
- Use of warfarin, i.e., Coumadin®, Jantoven® within 7 days prior to Day 1 (initial dosing)
- Intolerance or aversion to porcine ingredients that are used for the OMN54 oral capsules in the investigational medicine, OMN54 (Aneustat™).
- Known hypersensitivity to any of the three botanical constituents of Aneustat™ (OMN54), or other similar plants; or to plants belonging to Labiatae or Lamiaceae families, soy, or Aneustat™ (OMN54) excipients
- Use of Sophora subprostrata root (SSR) or herba serissae within 14 days prior to Day 1.
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)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Aneustat (OMN54)
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100 mg active/capsule; oral administration; 28 days/cycle (up to 6 cycles total) 1,000 mg QD 2,000 mg QD 1,500 mg BID 2,000 mg BID 2,500 mg BID
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
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Maximum Tolerated Dose (MTD) of two dosing regimens (once daily and twice daily)
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The maximum tolerated dose (MTD) is defined as the dose, based on data from 6 patients (or 5 patients if one patient has withdrawn due to non-Aneustat (OMN54) related reasons), below the non-tolerated dose (DL T).
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Dose Limiting Toxicity (DLT) of two dosing regimens (once daily and twice daily)
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Assessment per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
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Plasma blood concentrations of chemical markers
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These measurements are intended to characterize the pharmacokinetics of Aneustat (OMN54)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
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Tumor Response
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Tumor response as per RECIST criteria version 1.1, and tumor markers in plasma, as applicable
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Measurement of pathway biomarkers in plasma
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Plasma concentrations of cancer-related proteins to help characterize Aneustat (OMN54) activity
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 agosto de 2012
Finalización primaria (Actual)
1 de enero de 2014
Finalización del estudio (Actual)
1 de enero de 2014
Fechas de registro del estudio
Enviado por primera vez
13 de marzo de 2012
Primero enviado que cumplió con los criterios de control de calidad
14 de marzo de 2012
Publicado por primera vez (Estimar)
15 de marzo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de abril de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
7 de abril de 2015
Última verificación
1 de abril de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OMN54-101
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. .
Ensayos clínicos sobre Aneustat (OMN54)
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Omnitura Therapeutics, Inc.Vancouver Prostate CentreRetirado