Relation between docetaxel exposure + toxicity and lean body mass

Phase 1

• Conditions: Exposure and toxicity of docetaxel treatment with patients with breast or metastatic castration-resistant prostate carcinoma.; MedDRA version: 16.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005168-14-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-08
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Subject is at least 18
2.Subject is able and willing to sign the Informed Consent Form prior to screen-ing evaluations
3.Subject has been diagnosed with either breast or metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol
4.Subject has an live expectancy of 12 weeks or greater
5.Absolute neutrophile count (ANC) > 1.5 x 109/L
6.Platelet count > 100 x 109/L
7.Serum creatinine = 2 x ULN
8.Total bilirubin level < 1.5 x ULN

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Moderate or severe liver impairment; [ALAT and/or ASAT = 1.5 ULN] and [AF = 2.5 ULN]
2.Current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the docetaxel administration, known to inhibit or induce CYP3A4 as mentioned on the list in appendix A.
4.Inability to understand the nature and extent of the study and the procedures required

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC) for both males and females.;Secondary Objective: To determine if occurrence of docetaxel toxicity can be related to dose/Lean body mass.<br>To determine which methods to measure Lean body mass: DEXA, Bioelectrical Impedance As-sessment (BIA) or formula estimates are accurate enough to be used for dosing drugs.<br>;Primary end point(s): Correlation between Lean Body Mass, total body weight, body surface area and exposure of docetaxel (AUC).;Timepoint(s) of evaluation of this end point: Day one, first administration.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Correlation between dose/lean body mass and toxicitiy of docetaxel after first administration.;Timepoint(s) of evaluation of this end point: Until the next docetaxel administration or end of trial if earlier.