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

Part of paid clinical trials in Miami, Florida.

Sponsor
Exelixis
Study ID
NCT01761773
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 31, 2012
Status verified
Sep 2014
Primary completion
Apr 30, 2013
Completion
Jul 31, 2014

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Subjects with normal renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2.
  • Experimental: Group 2
    Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2.
  • Experimental: Group 3
    Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2.
  • Experimental: Group 4
    Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis.

Primary Outcome Measure

Pharmacokinetics [ Time Frame: Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22. ]

Locations (3)

FacilityCityStateZIPSite coordinators
-MiamiFlorida33136-
-OrlandoFlorida32809-
-Neptune CityNew Jersey07753-

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