Metastatic clear cell renal cell carcinoma
Conditions
Interventions
Trade Name: Votrient
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PAZOPANIB
CAS Number: 444731-52-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Cliniques Universitaires Saint Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Prior Immunotherapy is allowed - Woman or man = 18 Years old - Histologically proven metastatic clear cell (or at least clear cell predominant) RCC, sarcomatoid differentiation accepted - Subjects falling into conditions for reimbursement of sunitinib or pazopanib in the context of mRCC - Measurable disease based on RECIST criteria (version 1.1) - Subject has given voluntary written informed consent - Subject is in the investigator’s opinion, willing and able to comply with the protocol requirements - Subject has an ECOG = 2 - Subject with a life expectancy = 3 months - Concurrent treatment with bisphosphonates and denosumab is allowed however it should have been started before screening of the study. If possible starting new medications between the baseline metabolo- and lipidomotype- and the first metabolo- and lipidomotypeanalysis should be avoided - Subjects having recovered from side effects from previous therapies to a grade 1 CTC vs 4.0 criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patients with non-clear cell RCC - Patients presenting any other type of cancer disease within 5 years from inclusion into this study in the absence of cervical cancer or basocellular carcinoma - Patient had major surgery within 4 weeks before enrolment - Patient with myocardial infarction within 6 months prior enrolment or with NHYA class III otr IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia or electrocardiographic evidence of acute ischemia or active conduction system abnormalities - Patient has another serious medical condition that could potentially interfere with the completion of study - Subject known to be Sero-positive for HIV - Subject known to be hepatitis B surface antigen positive or who has an active hepatitis C infection - Subject has an active systemic infection requiring treatment - Female subject is pregnant or breast feeding - Subject enrolled in another clinical trial and/or receiving an investigational agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: General Objective: To assess whether certain metabonomic and or lipidomic features in correlation with pharmacokinetics before, during and after treatment with sunitinib or pazopanib in first line can predict toxicity and efficacy of sunitinib or pazopanib in metastatic clear cell renal cell carcinoma (mccRCC) patients. ;Secondary Objective: Pilot study:To determine the optimal time point after sunitinib or pazopanib to assess metabonomic and/or lipidomic features in correlation with PK before, during and after sunitinib or pazopanib and to correlate this with toxicity and efficacy of sunitinib or pazopanib in mccRcc patients. Main study:To identify a certain metabolo and/or lipidomotype characteristic for mccRCC.To identify metabonomic and/or lipidomic features before and during sunitinib or pazopanib which are predictive of toxicities in correlation with PK analysis.To correlate metabonomic,lipidomic and PK features before,during and after sunitinib or pazopanib with response,progression free survival and overall survival.To validate the association between the individual SNPs and outcome and/or dose reductions.To validate a scoring system combining several SNPs predicting outcome and/or dose reductions.To study the relationship between sunitinib/pazopanib plasma levels and SNPs involved in sunitinib/pazopanib PK;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium
Contacts
Public ContactJerome Degueldre
Cliniques Universitaires Saint-Luc
Outcome results
None listed