Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carci… (NCT02555748) | Clinical Trial Compass
CompletedPhase 4
Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma
France47 participantsStarted 2015-11-17
Plain-language summary
This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study.
Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).
The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma.
✓. Measurable tumours as defined by RECIST criteria version 1.1.
✓. Age ≥ 18 years old.
✓. WHO Performance Status ≤ 2.
✓. Life expectancy ≥ 6 months.
✓. Adequate cardiac function (baseline Left Ventricular Ejection Fraction (LVEF) ≥ 50% determined by Multiple Gated Acquisition scan (MUGA) or echocardiography) and pulmonary function.
✓. Renal function defined as creatinine clearance (Cockcroft and Gault formula) \> 30 mL/min.
✓. Adequate liver function defined as: total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN); Alanine AminoTansferase (ALAT) and Aspartate AminoTransferase (ASAT) ≤ 2.5 x ULN; Concomitant elevation in bilirubin and ASAT/ALAT above 1.0 x ULN is not allowed.
Exclusion criteria
✕
What they're measuring
1
Part I: Pharmacokinetics - Pazopanib or Sunitinib plasma concentrations
Timeframe: On day 1 and day 15 during cycle 1 and cycle 2 (cycle length is 6 weeks)
2
Part II: Tolerance - Proportion of patients without treatment discontinuation due to adverse event (AE) during the first year.
Timeframe: 5.5 years
3
Part II: Efficacy - Proportion of patients without progression at 1 year. This corresponds to the number of patients without progression at 1 year among the total number of patients in each group
Timeframe: 5.5 years
4
Part I: Adverse Events according to NCI toxicity scale (version 4.03)
. Patients without any venous access for blood sampling.
✕. Hypersensitivity to the active substance or to any of the excipients.
✕. History or clinical evidence of central nervous system (CNS) metastases, except for individuals who have previously-treated CNS metastases.
✕. Corrected QT interval (QTc) \> 480msecs using Bazett's formula.
✕. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
✕. Evidence of active bleeding or bleeding diathesis.
✕. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cytochrome P450 isoenzyme 3A4 (CYP3A4) within the last 14 days prior to inclusion and/or during the study.
✕. Patients already treated with an anticancer treatment in the previous four weeks or patient requiring anticancer treatment during the study (chemotherapy, immunotherapy, hormonotherapy, radiotherapy or surgery).