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

Purpose

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.

Condition	Intervention	Phase
Healthy Renal Impairment	Drug: cabozantinib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function

Resource links provided by NLM:

Drug Information available for: Cabozantinib

U.S. FDA Resources

Further study details as provided by Exelixis:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22. ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Safety and Tolerability [ Time Frame: Days 1 - 8 and Days 11, 13, 15, 18, 21, 22. ] [ Designated as safety issue: Yes ]
Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 60 mg dose in adult subjects with impaired renal function and in healthy adult subjects.

Estimated Enrollment:	24
Study Start Date:	December 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Subjects with normal renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2.	Drug: cabozantinib 3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation. Other Name: XL184
Experimental: Group 2 Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2.	Drug: cabozantinib 3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation. Other Name: XL184
Experimental: Group 3 Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2.	Drug: cabozantinib 3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation. Other Name: XL184
Experimental: Group 4 Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis.	Drug: cabozantinib 3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation. Other Name: XL184

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761773

Contacts

Contact: Exelixis Clinical Trials	1-888-393-5494	druginfo@exelixis.com
Contact: Secondary Contact	1-650-837-7400

Locations

United States, Florida
	Not yet recruiting
Miami, Florida, United States, 33136
Contact: Alberto Alonso 305-243-6795 aalonso2@med.miami.edu
	Recruiting
Orlando, Florida, United States, 32809
Contact: Thomas Marbury 407-240-7878 tmarbury@ocrc.net
United States, New Jersey
	Recruiting
Neptune, New Jersey, United States, 07753
Contact: Sushil Mehandru 732-502-8900 ext 24211 sushil.mehandru@celerion.com

Sponsors and Collaborators

Exelixis

More Information

No publications provided

Responsible Party:	Exelixis
ClinicalTrials.gov Identifier:	NCT01761773 History of Changes
Other Study ID Numbers:	XL184-017
Study First Received:	January 3, 2013
Last Updated:	January 4, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013