Farmas USA

Si, si, el que tu diguis.....

Au revoir....

ain ... que hembra ...

Tambien paso por el hormiguero, aunque no debio de gustarle nada ...

http://m.youtube.com/watch?v=Vdy7zLY7PPk&desktop_uri=%2Fwatch%3Fv%3DVdy7zLY7PPk
En fin, a ver si vivimos lo suficiente para que la realidad vitual avance y todos podamos tener una Charlize en nuestras vidas ... ;))))

Dicho esto y antes de volver al tema farmaceutico ...

Windsurd, es exactamente lo que pienso hacer. :)

CTIX, a ver si hoy seguimos con el subidón del viernes, probablemente almimentado por el artículo en SA....
Buscando, buscando, he visto que se esperan los primeros datos de Fase I para KEVETRIN en octubre...

http://clinicaltrials.gov/ct2/show/record/NCT01664000

Objetivo primario del estudio:
•Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.

The maximally administered dose is if 1 or more of 6 patients experience a DLT.

•Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]

The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
◦Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
◦Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
◦Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
◦Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit for supportive measures is 48 hours.

Objetivo secundario del estudio:

•Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 1 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ] [ Designated as safety issue: No ]

The pharmacokinetics (PK) of Kevetrin will be determined for all patients enrolled in the study on Day 1 of Cycle 1 and Day 15 of Cycle 2. Blood samples will be obtained before dosing, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion.

The pharmacokinetic profile will be analyzed by standard noncompartmental methods to provide estimated values of the pharmacokinetic parameters and associated variables, such as area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of Kevetrin. Associations between pharmacokinetic variables and drug-related toxicities will be evaluated.

•Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 15 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ] [ Designated as safety issue: No ]

The pharmacokinetics (PK) of Kevetrin will be determined for all patients enrolled in the study on Day 1 of Cycle 1 and Day 15 of Cycle 2. Blood samples will be obtained before dosing, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion.

The pharmacokinetic profile will be analyzed by standard noncompartmental methods to provide estimated values of the pharmacokinetic parameters and associated variables, including area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of Kevetrin. Associations between pharmacokinetic variables and drug-related toxicities will be evaluated.

•Change in tumor size [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging

•Change in tumor size [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging

•Change in tumor size [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Change in tumor size based on RECIST criteria version 1.1. using MRI, CT scan, and/or standard of care imaging

•Decrease in serum tumor marker [ Time Frame: baseline and 1 month ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

•Decrease in serum tumor marker [ Time Frame: baseline and 2 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

•Decrease in serum tumor marker [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

•Decrease in serum tumor marker [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

•Decrease in serum tumor marker [ Time Frame: baseline and 5 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

•Decrease in serum tumor marker [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
A decrease in a tumor marker in the serum may also suggest evidence of anti-tumor efficacy. The following tumor markers will be evaluated: Carcinoembryonic antigen (CEA), Cancer Antigen 125 (CA125), Cancer Antigen 19-9 (CA19-9), Cancer Antigen 15-3 (CA15-3), Prostate Specific Antigen (PSA), or other appropriate markers. The choice of the individual tumor markers will be based on the type of tumor of the patient and the testing that has preceded the patient's participation in this study.

•Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ] [ Designated as safety issue: No ]
For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.

•Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]
For biomarker analysis, p21 expression, assayed by qPCR, in peripheral blood lymphocytes after Kevetrin administration.

voy a tener que sacar los estiletes y cueros.
saco también la fusta??

;-))

Lo malo de los GAPs es que son pan para hoy y hueco para rellenar mañana.
Veremos que hace CLSN ... a que GAP mira ...

¿Me lo he ganado? Vale pues.

Esto es lo que tengo de material ahora mismo....

Un saludo

https://www.dropbox.com/sh/fgbdb5q1c0cgepz/u0n7mcTeB0

Decidme si lo podeis leer....

Un saludo