A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function

Exelixis

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy

Treatments: Drug: cabozantinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01761773

XL184-017

Details and patient eligibility

About

The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight must be ≥ 50 kg and < 130 kg with a BMI ≤ 38.0 (kg/m2).
• Must use acceptable form of birth control during the course of the study and for 3 months following the single dose of study drug.
• Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
• Negative test for HIV; hepatitis A, B, and C.
• Must have adequate vital sign reads at screening and check-in.
• Must be able to comply with dietary and fluid restrictions required for the study.

Exclusion criteria

• History of medical or surgical conditions that would interfere with GI absorption, distribution, metabolism, or excretion of the study drug.
• Recent clinical evidence of pancreatic injury.
• Recent use of drugs known to significantly inhibit or induce P450 CYP3A4 enzymes.
• Previous diagnosis of malignancy.
• Unwilling to forgo use of any over-the-counter or non-prescription preparations.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Group 1

Experimental group

Description:

Subjects with normal renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2.

Treatment:

Drug: cabozantinib

Group 2

Experimental group

Description:

Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2.

Treatment:

Drug: cabozantinib

Group 3

Experimental group

Description:

Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2.

Treatment:

Drug: cabozantinib

Group 4

Experimental group

Description:

Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis.

Treatment:

Drug: cabozantinib