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Cabo-POLARIS : A Trial to Evaluate Cabozantinib Among Haemodialysied Patients

NCT05241561 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-06-01

No results posted yet for this study

Summary

Among patients with renal cell carcinoma (RCC), 2.7 to 4.7 % of patients are at risk of progressing to dialysis or transplantation after partial and radical nephrectomy respectively. Of note, similar risk factors can be seen in both disease: RCC and renal impairment leading to dialysis. Currently, three types of systemic therapies (ST) are mainly used among patients with metastatic renal cell carcinoma (mRCC): anti-angiogenics (mostly tyrosine kinase inhibitors and bevacizumab), mTOR inhibitors and immune checkpoint inhibitor.

ST prescription for patients undergoing HD may be more dangerous than in other patients. This is partially explained by the fact that several adverse events can be induced by both the ST and HD e.g. thromboembolic disease, or hypertension.

Patients in HD are usually excluded from major clinical trials and available data concerning safety and activity of ST in this specific population are lacking. In most cases, drugs' label is driven by the eligibility criteria of large randomized phase 3 trials that exclude this type of patients. The main source of information for these patients comes from academic publications of patients' cases or small cohorts, but they are not included within the drug label. Moreover, no clear guidelines are given by savant societies regarding those patients.

It is known that patients with HD are at high risk of specific adverse events that can sometimes overlap with the safety profile of anti-cancer drugs: thromboembolic complications, cardio-vascular comorbidities, hematologic and metabolic abnormalities.

Having a dedicated clinical trial to this particular population would definitely help the community to improve the care of HD patients by getting prospective data in order to increase the level of evidence and therefore to optimize anticancer drug use in this specific population.

Conditions

  • Cancer of Kidney

Interventions

DRUG

Cabozantinib

Cabozantinib will be prescribed following its Marketing Authorization with an initiation at a reduced dose of 40 mg per day. The dose will be adjusted according to safety. At the end of the first cycle, patients may be eligible for an increase in the dose of cabozantinib (up to 60 mg per day) if the following criteria are met: no adverse effects of grade 3 or 4 cabozantinib-related, no dose reduction or interruption for safety reasons, no long-lasting grade 2 cabozantinib-related adverse effects requiring maximum supportive care. Continuation to 40 mg per day or reduction to 20 mg per day are the other alternatives depending on the safety profile.

BIOLOGICAL

Blood sample

biomonitoring and pharmacokinetics

OTHER

Questionnaires of quality of life

FKSI-19 and FKSI-DRS and EUROQOL EQ-5D-5L

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241561 on ClinicalTrials.gov