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

NCT01761773 | Completed Phase 1 DMC

• 1 other identifier: XL184-017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  AUC, Cmax, tmax, kel, t1/2, CL/F, V/F and fu as measure of a single oral 60 mg dose of cabozantinib in adults with impaired renal function compared with healthy subjects matched for age, gender, and body mass index (BMI). Subjects will receive a single oral 60 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 - 8 following this single dose, as well as on the mornings of Days 11, 13, 15, 18, 21, 22.

  Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22.

Secondary Outcomes (1)

• Safety and Tolerability

  Days 1 - 8 and Days 11, 13, 15, 18, 21, 22.

Study Arms (4)

Group 1

EXPERIMENTAL

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

Drug: cabozantinib

Group 2

EXPERIMENTAL

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

Drug: cabozantinib

Group 3

EXPERIMENTAL

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

Drug: cabozantinib

Group 4

EXPERIMENTAL

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

Drug: cabozantinib

Interventions

cabozantinib DRUG

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

Also known as: XL184

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (3)

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

Neptune City, New Jersey, 07753, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 7, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (3)