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Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer

ConditionKidney Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

About this trial

The study of the blood concentration of ITK what are pazopanib and cabozantinib at 1 month and 3 months from the start of treatment will allow to evaluate the impact of renal failure on their efficacy and toxicity in patients with metastatic kidney cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient followed for metastatic clear cell renal cell carcinoma.

Age ≥18 years old.

Performance Status (PS) according to Eastern Cooperative Oncology Group (ECOG) = 0, 1 or 2

Patient treated with a VEGF-R inhibitor: pazopanib or cabozantinib for metastatic kidney cancer.

Disqualifiers

Indication other than clear cell renal cell carcinoma for these same ITKs

Pregnant or breast-feeding subjects

Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons,

Patient under guardianship, curatorship or safeguard of justice

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood sampling for ITK dosage

    Other intervention

    Blood sample for ITK dosage at visit 1 (1 month +/- 1 week after the start of treatment) and at visit 2 (3 months +/- 1 month after the start of treatment)

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Patients without renal insufficiency under pazopanibOther 1 intervention
Group B: Patients without renal insufficiency under cabozantinibOther 1 intervention
Group C: Patients with moderate renal impairment under pazopanibOther 1 intervention
Group D: Patients with moderate renal impairment under cabozantinibOther 1 intervention
Group E: Patients with severe or terminal stage renal impairment under pazopanibOther 1 intervention
Group F: Patients with severe or terminal stage renal impairment under cabozantinibOther 1 intervention

Trial outcomes

Primary outcomes

1

Residual concentration at equilibrium of ITK in the blood

Assessment in patients treated for metastatic kidney cancer without or with moderate or severe renal impairment if the plasma concentration (residual concentration at equilibrium) of ITK is higher than the target concentration (specific to the ITK molecule : pazopanib : 20 000 ng/mL and cabozantinib : 1000 ng/mL )

Time frame
at 1 month (+/1 week)

Secondary outcomes

1

Concentration of ITK in the blood in patients with Failure renal function

Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with moderate renal impairment and / or severe renal impairment

Time frame
at 1 month (+/- 1 week) and 3 months (+/- 1 month)
2

Concentration of ITK in the blood in patients with normal renal function

Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with normal renal function

Time frame
at 1 month (+/- 1 week) and 3 months (+/- 1 month)
3

Toxicities related to the intake of ITKs

Assessment toxicities induced by the use of ITK targeting Vascular Endothelial Growth Factor-Receptor (VEGF-R) by using the NCI-CTCAE version 5.0 (grade ≥ 2)

Time frame
at 1 month (+/- 1 week) and 3 months (+/- 1 month)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut du Cancer de Montpellier - Val d'Aurelle

Lead sponsor

Ligue contre le cancer, France

Collaborator

Source ClinicalTrials.gov
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