Evaluation of predictive markers for toxicity and efficacy in patients with metastatic clear cell renal cell carcinoma treated by anti VEGF therapy.

Phase 1

• Conditions: Metastatic clear cell renal cell carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006085-40-BE
• Lead Sponsor: Cliniques Universitaires Saint Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-10
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

- Prior Immunotherapy is allowed
- Woman or man = 18 Years old
- Histologically proven metastatic clear cell (or at least clear cell predominant) RCC, sarcomatoid differentiation accepted
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Patients with non-clear cell RCC
- 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
- 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
- Subject known to be 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified