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

NCT02570789 | Terminated Phase 4 DMC

• 1 other identifier: UCL-ONCO 2012-09
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

patients with sunitinib or pazopanib

EXPERIMENTAL

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

Interventions

patients with sunitinib or pazopanib DRUG

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

patients with sunitinib or pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with non-clear cell RCC and/or with sarcomatoid differentiation,
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Interventions

Sunitinib; pazopanib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jean-Pascal Machiels, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: October 7, 2015
• Study Start: December 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

BE (1)