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Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects

Sponsor
Exelixis (Industry)
Overall Status
Completed
CT.gov ID
NCT01493869
Collaborator
(none)
26
Enrollment
1
Location
4
Arms
35
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Subjects with normal hepatic function: healthy normal adult subjects

Drug: cabozantinib
3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
Other Names:
  • XL184

    		•
    Experimental: Group 2

    Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).

    Drug: cabozantinib
    3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
    Other Names:
  • XL184

    		•
    Experimental: Group 3

    Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).

    Drug: cabozantinib
    3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
    Other Names:
  • XL184

    		•
    Experimental: Group 4

    Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).

    Drug: cabozantinib
    3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
    Other Names:
  • XL184

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity [Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22]

      Subjects will receive a single oral 75 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 through 5 following this single dose, as well as on the mornings of Days 6, 8, 11, 15, 19, 21, and 22.

    Secondary Outcome Measures

    1. Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 75 mg dose in hepatic impaired adult subjects and healthy adult subjects [Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body weight must be ≥50 kg and <130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).

    • Must use acceptable forms 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.

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McGuire VA Medical Center Richmond Virginia United States 23249

    Sponsors and Collaborators

    • Exelixis

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exelixis
    ClinicalTrials.gov Identifier:
    NCT01493869
    Other Study ID Numbers:
    • XL184-003
    First Posted:
    Dec 16, 2011
    Last Update Posted:
    Sep 22, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Exelixis
    Normal healthy adult subjects
    Adult subjects with hepatic impairment
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Sep 22, 2014