FASE IV

FASE TRES B

INVESTIGACIÓN CLÍNICA FARMACÉUTICA FASE TRES

INVESTIGACIÓN CLÍNICA FARMACÉUTICA FASE II

INVESTIGACION CLINICA FASE UNO

ACTIVIDADES EN LINEA

ESTIMADO ALUMNOS

LES ENVIO PROTOCOLOS FASE I, LA ACTIVIDAD CONSISTE EN QUE IDENTIFIQUE SUS PARTES PARA ANALIZARLOS EN CLASE EN CENTRO MEDICO, ESTE SABADO, LOS PROTOCOLOS FASE II, III, Y VI. ESTARAN DISPONIBLES MAS TARDE, LES INVITO A INGRESAR FRECUENTEMENTE PARA LAS ACTIVIDADES.

GRACIAS.
DR. SORIANO PA.

PROTOCOLO FASE I (EJEMPLO)

Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

This study has been completed.

First Received on November 22, 2004.   Last Updated on July 18, 2006 

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00097383

  Purpose

This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.

Condition	Intervention	Phase
Breast Cancer	Drug: ALIMTA plus Epirubicin	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Primary Purpose: Treatment
Official Title:	A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

  Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment.
• Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
• Patients must have at least one measurable lesion in an area not previously irradiated.
• No chemotherapy at least 4 weeks prior to study enrollment.
• Signed informed consent from patient.

Exclusion Criteria:

• Treatment with any drug within the last 30 days that has not received regulatory approval.
• Serious systemic disorders, including active infection.
• Significant cardiovascular disease.
• Pregnancy or breast feeding.
• Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

PROTOCOLO FASE I (EJEMPLO)

Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

This study has been completed.

First Received on October 21, 2004.   Last Updated on July 18, 2006

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00094640

  Purpose

The goals of this study are to:

Determine the blood levels of intramuscular (IM) olanzapine depot in patients at different points in time after an injection, and compare these levels to the amount of olanzapine in the blood of patients after treated by oral administration with Zyprexa (olanzapine) tablets or by intramuscular administration with Zyprexa IntraMuscular (olanzapine for injection).

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Intramuscular Olanzapine Depot	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients must have schizophrenia or schizoaffective disorders.
• Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent.
• Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.
• Female patients must not be pregnant or breast-feeding.
• Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or schizoaffective disorder.

INICIO

LES ENVÍO UN CORDIAL SALUDO Y AL MISMO TIEMPO LE INVITO A EXPLORAR CONTINUAMENTE ESTE BLOG SPOT Y DESCARGAR TODO SU CONTENIDO ASÍ COMO SUS BIBLIOTECAS.

ATENTAMENTE

DR. SORIANO PA.