Evaluation of Predictive Markers for Toxicity and Efficacy in Patients With mccRCC Treated by Anti-VEGF Therapy

NCT ID: NCT02570789

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2021-03-01

Brief Summary

The purpose of this study is to assess whether certain metabonomics and/or lipidomics 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 patients.

Conditions

Clear-cell Metastatic Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

patients with sunitinib or pazopanib

This will be a non-randomized, proof-of-concept, prospective, longitudinal, multi-center study in patients with metastatic clear cell renal cell carcinoma with good or intermediate risk (based on MSKCC criteria) treated with sunitinib or pazopanib in first line.

Group Type: EXPERIMENTAL

patients with sunitinib or pazopanib

Intervention Type: DRUG

The treatment with sunitinib or pazopanib should comply with the recommendations written in the Belgian product information and the reimbursement criteria

Interventions

patients with sunitinib or pazopanib

The treatment with sunitinib or pazopanib should comply with the recommendations written in the Belgian product information and the reimbursement criteria

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Woman or man ≥ 18 Years old, histologically proven metastatic clear cell (or al least clear cell predominant) RCC,
• Good or intermediate risk according to MSKCC-criteria, 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

Exclusion Criteria

• Patients with non-clear cell RCC and/or with sarcomatoid differentiation,
• 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, Patients with uncontrolled arterial hypertension,
• Patients with uncontrolled hypo- or hyperthyroidism,
• 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,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pascal Machiels, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

UCL-ONCO 2012-09

Identifier Type: -

Identifier Source: org_study_id