A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
This study has been completed.
Sponsor:
Exelixis
ClinicalTrials.gov Identifier:
NCT01761773
First Posted: January 7, 2013
Last Update Posted: September 22, 2014
Information provided by (Responsible Party):
Exelixis
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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 Intervention Model: Parallel Assignment Masking: None (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:
MedlinePlus related topics:
Kidney Tests
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. ]
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. ]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.
| Enrollment: | 32 |
| Study Start Date: | December 2012 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | April 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 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 ≤ 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
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): NCT01761773
Locations
| United States, Florida | |
| Miami, Florida, United States, 33136 | |
| Orlando, Florida, United States, 32809 | |
| United States, New Jersey | |
| Neptune, New Jersey, United States, 07753 | |
Sponsors and Collaborators
Exelixis
More Information
| Responsible Party: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT01761773 History of Changes |
| Other Study ID Numbers: |
XL184-017 |
| First Submitted: | January 3, 2013 |
| First Posted: | January 7, 2013 |
| Last Update Posted: | September 22, 2014 |
| Last Verified: | September 2014 |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |