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Metastatic Renal Cell CancerPhase 4SUP-RNCT02555748

Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma

A Phase 4 study testing Pazopanib and Sunitinib in people with Metastatic Renal Cell Cancer, run by Institut Claudius Regaud at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study. Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Cancer
What is being tested?
Pazopanib and Sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
8 sitesFrance
Study dates
17 Nov 2015to 16 Jan 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma.
  • Measurable tumours as defined by RECIST criteria version 1.1.
  • Age ≥ 18 years old.
  • WHO Performance Status ≤ 2.
  • Life expectancy ≥ 6 months.
  • Adequate cardiac function (baseline Left Ventricular Ejection Fraction (LVEF) ≥ 50% determined by Multiple Gated Acquisition scan (MUGA) or echocardiography) and pulmonary function.
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  • Renal function defined as creatinine clearance (Cockcroft and Gault formula) > 30 mL/min.
  • 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.
  • 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.
  • Negative pregnancy test for women in childbearing potential.
  • 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).
  • Patients affiliated to a social health insurance.

Who cannot join

  • Patients without any venous access for blood sampling.
  • Hypersensitivity to the active substance or to any of the excipients.
  • History or clinical evidence of central nervous system (CNS) metastases, except for individuals who have previously-treated CNS metastases.
  • Corrected QT interval (QTc) > 480msecs using Bazett's formula.
  • 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.
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  • 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.
  • Evidence of active bleeding or bleeding diathesis.
  • 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.
  • 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).
  • Pregnant or breast-feeding women.
  • Positive diagnostic of HIV, B and C hepatitis.
  • 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.
  • Patients who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • CHU DE BORDEAUX - Hôpital Saint-André

    Bordeaux, 33035

  • Institut Bergonie

    Bordeaux, 33076

  • CHU DE LIMOGES - Hôpital Dupuytren

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Institut Regional Du Cancer Montpellier

    Montpellier, 34298

  • CH RODEZ

    Rodez, 12027

  • Institut Claudius Regaud

    Toulouse, 31059

Other trials in France

About this study

This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study.

Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).

The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation.

Being tested
Pazopanib, Sunitinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02555748
Study groupRoleWhat they receive
PazopanibActive comparatorThe daily dose of pazopanib will be the standard dose i.e. 800 mg once a day (2 tablets of 400 mg in one oral administration per day) administered each day, continuously, during the treatment phase (complete cycle will be defined as a 6-week period). During the first stage of the study (Part I), adjustment of drug dose will be made according to individual patient tolerance to treatment evaluated by clinical and biological monitoring; During the second stage of the study (Part II), dose modification should also be performed according to individual patient tolerance to treatment evaluated by clinical and biological monitoring ans also by using the new Pharmacokinetic-Pharmacodynamic (PK-PD) Algorithm elaborated during the first part.
Receives: Drug: Pazopanib
SunitinibActive comparatorSunitinib will be administered at the standard dose of 50 mg, once daily during 4 consecutive weeks, followed by a wash-out period of 2 weeks (corresponding to a complete cycle of 6 weeks). During the first stage of the study (Part I), dose adjustment of drug dose will be made according to individual patient tolerance to treatment evaluated by clinical and biological monitoring; During the second stage (Part II), dose modification should also be performed according to individual patient tolerance to treatment evaluated by clinical and biological monitoring ans also by using the new Pharmacokinetic-Pharmacodynamic (PK-PD) Algorithm elaborated during the first part.
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part I: Pharmacokinetics - Pazopanib or Sunitinib plasma concentrations

    Measured: On day 1 and day 15 during cycle 1 and cycle 2 (cycle length is 6 weeks)

  2. Part II: Tolerance - Proportion of patients without treatment discontinuation due to adverse event (AE) during the first year.

    This corresponds to the number of patients without treatment discontinuation due to AE among the total number of patients in each group.

    Measured: 5.5 years

  3. Part II: Efficacy - Proportion of patients without progression at 1 year. This corresponds to the number of patients without progression at 1 year among the total number of patients in each group

    Measured: 5.5 years

  4. Part I: Adverse Events according to NCI toxicity scale (version 4.03)

    Measured: 1.5 years

Secondary outcomes (5)

  1. Part I and II: Objective Response (e.g. Complete or Partial Response)

    Objective Response will be defined using RECIST Criteria version 1.1.

    Measured: 5.5 years

  2. Part I and II:- Progression free survival.

    Progression free survival is defined as the time from inclusion until progression (RECIST Criteria version 1.1) or death. Patients alive at last follow-up news are censored at this date.

    Measured: 5.5 years

  3. Part I and II: Safety according to the classification of the NCI: Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.03.

    Measured: 5.5 years

  4. Part I and II: Hand-foot syndrome (HFS)

    Hand-foot syndrome (HFS) will be evaluated using the HFS-14 questionnaire. This scale specifically developed for patients with HFS is a valid and valuable tool for measuring HFS-related QoL impairment.

    Measured: 5.5 years

  5. Part I and II: Quality of life using the quality of life questionnaire (QLQ)-C30

    Quality of life will be evaluated using the QLQ-C30 questionnaire

    Measured: 5.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study start17 Nov 2015
  3. Primary completion16 Jan 2020
  4. Study completion16 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555748
Sponsor's protocol ID
14 URO 06
Acronym
SUP-R
Status last verified
Mar 2026
First submitted
4 Sep 2015
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Le Louedec F, Morvan L, Mourey L, Maillard M, Vachoux C, Yakoubi M, Tosi D, Gravis G, Roubaud G, Thuillier F, Boyle H, Thomas F, White-Koning M, Puisset F, Chatelut E. Model-Informed Precision Dosing of Protein Kinase Inhibitors: Evaluation of Model-Averaging and Flattened Priors Methods. Clin Pharmacokinet. 2026 May;65(5):681-692. doi: 10.1007/s40262-026-01628-2. Epub 2026 Mar 9.

    PubMed 41801644

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pazopanib and Sunitinib in people with Metastatic Renal Cell Cancer, run by Institut Claudius Regaud at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part I: Pharmacokinetics - Pazopanib or Sunitinib plasma concentrations (time frame: On day 1 and day 15 during cycle 1 and cycle 2 (cycle length is 6 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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