We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 82 for:    cabozantinib

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493869
First Posted: December 16, 2011
Last Update Posted: September 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Exelixis
  Purpose
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 Intervention Phase
Healthy Hepatic Impairment Drug: cabozantinib Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • 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 [ Time Frame: 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:
  • 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 [ Time Frame: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22 ]

Enrollment: 26
Study Start Date: September 2011
Study Completion Date: August 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: XL184

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493869


Locations
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Exelixis
  More Information

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01493869     History of Changes
Other Study ID Numbers: XL184-003
First Submitted: October 11, 2011
First Posted: December 16, 2011
Last Update Posted: September 22, 2014
Last Verified: September 2014

Keywords provided by Exelixis:
Normal healthy adult subjects
Adult subjects with hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases