Clinical study to evaluate the effect of sunitinib ans pazopanib blood levels over time and other parameters in patients with kidney cell cancer.

A single arm Pharmacokinetic/Pharmacodynamic Study of Sunitinib and Pazopanib in Patients with Metastasized Renal Cell Carcinoma - EuT-PK/PD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001415-23-DE

Enrollment

100

Registered

2012-07-09

Start date

2012-10-17

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasized renal cell carcinoma MedDRA version: 14.1 Level: PT Classification code 10038414 Term: Renal cell carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Sutent Pharmaceutical Form: Capsule INN or Proposed INN: SUNITINIB CAS Number: 557795-19-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female or male patients of 18 years of age or older Diagnosed with metastasized renal cell cancer not yet having received treatment for their disease in the metastatic setting All study subjects have to participate in the non-interventional study (NIS) EuroTARGET First-line therapy with sunitinib or pazopanib planned Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier method of contraception), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active male patients must also use acceptable contraceptive methods (condom). 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Unable to read or understand the patient information and informed consent form Existing contraindication for sunitinib or pazopanib

Design outcomes

Primary

Measure	Time frame
Main Objective: Develop PK/PD models for sunitinib and pazopanib including biomarker response (blood pressure, sVEGFR-2, sVEGFR-3) as PD marker ;Secondary Objective: Integrate clinical outcome (e.g. response) and toxicity into the PK/PD models Integrate genotypes and compliance into the PK/PD models Explorer the applicability of the developed models: --> predict response and toxicity based on individual PK and biomarker response --> detect resistance based on time-dependent alterations in biomarker response ;Primary end point(s): Since it is not the intention of this study to test a formal hypothesis no primary endpoint is defined.;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: Develop PK/PD models for sunitinib and pazopanib including biomarker response (blood pressure, sVEGFR-2, sVEGFR-3) as PD marker ;Secondary Objective: Integrate clinical outcome (e.g. response) and toxicity into the PK/PD models Integrate genotypes and compliance into the PK/PD models Explorer the applicability of the developed models: --> predict response and toxicity based on individual PK and biomarker response --> detect resistance based on time-dependent alterations in biomarker response ;Primary end point(s): Since it is not the intention of this study to test a formal hypothesis no primary endpoint is defined.;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Since it is not the intention of this study to test a formal hypothesis no secondary endpoint is defined. ;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Germany

Contacts

Public ContactCESAR

Central European Society for Anticancer Drug Research - EWIV

office@cesar.or.at00431 522 30 93 10

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026