Blood tests could Fine-Tune kidney cancer treatment
NCT ID NCT02555748
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether measuring drug levels in the blood can help doctors adjust doses of two common kidney cancer medications, sunitinib and pazopanib. The goal was to see if this personalized approach reduces side effects and keeps the cancer from growing longer than the standard method of dosing based on side effects alone. The study enrolled 47 patients with advanced or metastatic renal cell carcinoma starting these drugs as their first treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sunitinib and pazopanib
- What this could lead to
- If successful, this approach could help doctors personalize dosing of these drugs to reduce side effects and improve treatment effectiveness for kidney cancer patients.
- What could go wrong
- This is a small pilot study with only 47 participants, so results may not apply to everyone. The approach adds complexity and may not significantly improve outcomes over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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47 people
The number who actually took part.
- Started
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Nov 2015
- Finished
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Jan 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma. 2. Measurable tumours as defined by RECIST criteria version 1.1. 3. Age ≥ 18 years old. 4. WHO Performance Status ≤ 2. 5. Life expectancy ≥ 6 months. 6. Adequate cardiac function (baseline Left Ventricular Ejection Fraction (LVEF) ≥ 50% determined by Multiple Gated Acquisition scan (MUGA) or echocardiography) and pulmonary function. 7. Renal function defined as creatinine clearance (Cockcroft and Gault formula) \> 30 mL/min. 8. Adequate liver function defined as: total bilirubin ≤ 1.5 x Upper Limit of Normal (ULN); Alanine AminoTansferase (ALAT) and Aspartate AminoTransferase (ASAT) ≤ 2.5 x ULN; Concomitant elevation in bilirubin and ASAT/ALAT above 1.0 x ULN is not allowed. 9. Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. 10. Negative pregnancy test for women in childbearing potential. 11. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study (before study entry and until 30 days after the last administration of study treatment). 12. Patients affiliated to a social health insurance. Exclusion Criteria: 1. Patients without any venous access for blood sampling. 2. Hypersensitivity to the active substance or to any of the excipients. 3. History or clinical evidence of central nervous system (CNS) metastases, except for individuals who have previously-treated CNS metastases. 4. Corrected QT interval (QTc) \> 480msecs using Bazett's formula. 5. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to: * Uncontrolled infection. * Cardiovascular conditions within the last 6 months such as cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New-York Heart Association (NYHA), clinically significant irregular heartbeat requiring medication. * Poorly controlled hypertension \[defined as systolic blood pressure of ≥140 mmHg or diastolic pressure of ≥90 mmHg). * History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or deep venous thrombosis (DVT) within the past 6 months. Note: patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible. 6. Evidence of active bleeding or bleeding diathesis. 7. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cytochrome P450 isoenzyme 3A4 (CYP3A4) within the last 14 days prior to inclusion and/or during the study. 8. Patients already treated with an anticancer treatment in the previous four weeks or patient requiring anticancer treatment during the study (chemotherapy, immunotherapy, hormonotherapy, radiotherapy or surgery). 9. Pregnant or breast-feeding women. 10. Positive diagnostic of HIV, B and C hepatitis. 11. Patients with serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures. 12. Patients who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CH RODEZ
Rodez, 12027, France
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CHU DE BORDEAUX - Hôpital Saint-André
Bordeaux, 33035, France
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CHU DE LIMOGES - Hôpital Dupuytren
Limoges, 87042, France
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Centre Leon Berard
Lyon, 69373, France
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Institut Bergonie
Bordeaux, 33076, France
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Institut Claudius Regaud
Toulouse, 31059, France
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Institut Paoli Calmettes
Marseille, 13273, France
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Institut Regional Du Cancer Montpellier
Montpellier, 34298, France
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