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

Primary Purpose

Clear-cell Metastatic Renal Cell Carcinoma

Status

Terminated

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

patients with sunitinib or pazopanib

About this trial

This is an interventional basic science trial for Clear-cell Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cliniques universitaires Saint-Luc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with sunitinib or pazopanib

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment assessment by using RECIST 1.1 and adverse events will be documented using the NCI-CTC coding system (version 4.0)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02570789

First Posted

September 17, 2015

Last Updated

March 18, 2021

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT02570789

Brief Title

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

Acronym

METASUN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

not enough accrual

Study Start Date

December 2012 (undefined)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clear-cell Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patients with sunitinib or pazopanib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

patients with sunitinib or pazopanib

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment assessment by using RECIST 1.1 and adverse events will be documented using the NCI-CTC coding system (version 4.0)

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Pascal Machiels, MD, PhD

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussel

ZIP/Postal Code

1200

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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