Dataset Information

PHARMACOKINETIC PERSPECTIVE STUDY IN COLORECTAL CANCER PATIENTS AND CANDIDATE FOR FLUOROPYRIMIDINE THERAPY: 5-FLUORO TEST

ABSTRACT: Primary objectives: - To evaluate 5-FU e 5-FDHU pharmacokinetic parameters after a test-dose administration (5-FU 250 mg/mq ev. bolus) - To analyse possible correlations between pharmacokinetic results and adjuvant or first line treatment tolerability in colorectal cancer patients - To exclude from fluoropyrimidine therapy patients with significant alterations of 5-FU and 5-FDHU pharmacokinetics (CL<1 l/h/mq, T1/2β>5 h, and Cmax<0.1 µg/ml, Tmax>60 min, respectively) after the administration of the 5-FU test-dose Primary endpoints: - HPLC measurements of 5-FU and 5-FDHU plasma concentrations and calculation of the main pharmacokinetic parameters with the software WinNonlin 5.1 (Pharsight Corporation, USA). - Toxicity data collection and univariate/multivariate statistical analysis of the kinetics results. - Pharmacokinetic analysis and comparison of the results of single patients with the population previously published [Bocci et al. 2006].

DISEASE(S): Colo-rectal Adenocarcinoma.,Colorectal Cancer

PROVIDER: 2522689 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

Project description:Interventions: Arm 1: 25 mg/mL BP01 (bevacizumab biosimilar) administered as single intravenous infusion of 1 mg/kg over a period of approximately 90 minutes. Primary outcome(s): To determine the pharmacokinetic profile of BP01 following a single intravenous administration of 1 mg/kg in healthy male subjects. PK parameters determined are to include AUC(0-inf), AUC(0-t), C(max), residual area, T(max), T(1/2 el), K(el), Cl and V(d).[Blood PK samples will be collected for analysis during the treatment period at: pre-infusion (0 hour), prior to end of infusion (within 5 minutes before end of infusion), and at 2, 4, 6, 9, 12, 24, 48 (Day 3), 72 (Day 4), 168 (Day 8), 336 (Day 15), 504 (Day 22), 1008 (Day 43), 1512 (Day 64), and 2016 hours (Day 85).];To determine the pharmacokinetic profile of US-licensed Avastin following a single intravenous administration of 1 mg/kg in healthy male subjects. PK parameters determined are to include AUC(0-inf), AUC(0-t), C(max), residual area, T(max), T(1/2 el), K(el), Cl and V(d).[Blood PK samples will be collected for analysis during the treatment period at: pre-infusion (0 hour), prior to end of infusion (within 5 minutes before end of infusion), and at 2, 4, 6, 9, 12, 24, 48 (Day 3), 72 (Day 4), 168 (Day 8), 336 (Day 15), 504 (Day 22), 1008 (Day 43), 1512 (Day 64), and 2016 hours (Day 85).];To determine the pharmacokinetic profile of EU-licensed Avastin following a single intravenous administration of 1 mg/kg in healthy male subjects. PK parameters determined are to include AUC(0-inf), AUC(0-t), C(max), residual area, T(max), T(1/2 el), K(el), Cl and V(d).[Blood PK samples will be collected for analysis during the treatment period at: pre-infusion (0 hour), prior to end of infusion (within 5 minutes before end of infusion), and at 2, 4, 6, 9, 12, 24, 48 (Day 3), 72 (Day 4), 168 (Day 8), 336 (Day 15), 504 (Day 22), 1008 (Day 43), 1512 (Day 64), and 2016 hours (Day 85).] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Bio-equivalence

Dataset Information

PHARMACOKINETIC PERSPECTIVE STUDY IN COLORECTAL CANCER PATIENTS AND CANDIDATE FOR FLUOROPYRIMIDINE THERAPY: 5-FLUORO TEST

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure