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

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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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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