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

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ClinicalTrials.gov Identifier: NCT02570789
Recruitment Status : Active, not recruiting
First Posted : October 7, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Clear-cell Metastatic Renal Cell Carcinoma Drug: patients with sunitinib or pazopanib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : December 2012
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


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




Primary Outcome Measures :
  1. 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 Measures :
  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 [ Time Frame: up to 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570789


Locations
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Belgium
Cliniques universitaires Saint-Luc
Brussel, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Jean-Pascal Machiels, MD, PhD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02570789     History of Changes
Other Study ID Numbers: UCL-ONCO 2012-09
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Bevacizumab
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological