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

NCT ID: NCT01761773

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Healthy; Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Group 2

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

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Group 3

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

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Group 4

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

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Interventions

cabozantinib

3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.

Intervention Type: DRUG

Other Intervention Names

XL184

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Exelixis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Miami, Florida, United States

Orlando, Florida, United States

Neptune City, New Jersey, United States

Countries

United States

Other Identifiers

XL184-017

Identifier Type: -

Identifier Source: org_study_id