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

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40825

Enrollment

Registered

2014-07-02

Start date

2014-07-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

advanced kidney cancer + metastatic renal cell carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - female or male patients of 18 years of age or older - diagnosed with metastatic renal cell carcinoma and not yet having received treatment for their disease in the metastatic setting - first-line treatment with either sunitinib or pazopanib

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
For development of the pharmacokinetic/pharmacodynamic model, for every patient a maximu of 12 blood samples will be taken within the time frame of this study and within 3 cycles of sunitinib treatment or within 18 weeks of pazopanib treatment. These blood samples will be used to determine the blood plasma levels for sunitinib, the active metabolite of sunitinib (SU12662), pazopanib and VEGFR2 and VEGFR3. Further, there will be blood pressure measurements at regular intervals. Demographic and patient specific data will be completed in electronical Case Report Forms (CRFs) as a part of the total EuroTARGET project. After completion of the PK/PD model de blood samples will be used to extract DNA and to determine patient specific genotypes. These genotypes will be used as covariates in the PK/PD model.	—

Measure

Time frame

For development of the pharmacokinetic/pharmacodynamic model, for every patient a maximu of 12 blood samples will be taken within the time frame of this study and within 3 cycles of sunitinib treatment or within 18 weeks of pazopanib treatment. These blood samples will be used to determine the blood plasma levels for sunitinib, the active metabolite of sunitinib (SU12662), pazopanib and VEGFR2 and VEGFR3. Further, there will be blood pressure measurements at regular intervals. Demographic and patient specific data will be completed in electronical Case Report Forms (CRFs) as a part of the total EuroTARGET project. After completion of the PK/PD model de blood samples will be used to extract DNA and to determine patient specific genotypes. These genotypes will be used as covariates in the PK/PD model.

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Countries

Netherlands

Outcome results