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

A Proof of Concept Study to Evaluate the Use of Metabonomics and Lipidomics in Predicting Toxicity and Efficacy of Anti-VEGF Therapy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

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.

Study Overview

• Status: Terminated
• Conditions: Clear-cell Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Drug: patients with sunitinib or pazopanib

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1200
    • Cliniques Universitaires Saint-luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment assessment by using RECIST 1.1 and adverse events will be documented using the NCI-CTC coding system (version 4.0)	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Identifying the level metabolotype and/or lipidomotype of metastatic clear cell renal cell carcinoma patients before starting sunitinib or pazopanib (in comparison with healthy volunteers) on blood and urine samples by biochemistry techniques	up to 5 years

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: UCL-ONCO 2012-09