Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT07077161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
Sponsor:
dr. Tom van der Hulle
Organization:
Study Overview
Official Title:
Cabozantinib Dose Skipping as an Alternative to Dose Reductions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKIPPY 2
Brief Summary:
The goal of this study is to determine if an alternative cabozantinib dosing regimens results in a similar drug exposure compared to the standard regimens in patients with metastatic renal cell carcinoma (mRCC). All dosages of cabozantinib (20 ,40, 60mg) have the same price, and cabozantinib is eliminated very slowly by the body. This means that using fewer tablets could potentially lead to cost savings, while remaining equally effective.
The main questions it aims to answer are:
* Is the drug exposure from our experimental regimens similar to the standard dosing regimens?
* Do the experimental regimens affect the number of side effect and the patients' quality of life?
Participants will:
* Take cabozantinib according to either the experimental or standard dosage regimen for 4 weeks
* After 4 weeks: visit the clinic to collect some blood samples and complete two questionnaires.
* 1 and 3 days after this visit: visit the clinic to collect 1 blood sample.
* The day after the hospital visit: switch to the other dosing regimen and according to that regimen for another 4 weeks.
* After 4 weeks: visit the clinic to collect some blood samples and complete two questionnaires
* 1 and 3 days after this visit: visit the clinic to collect 1 blood sample.
The main questions it aims to answer are:
* Is the drug exposure from our experimental regimens similar to the standard dosing regimens?
* Do the experimental regimens affect the number of side effect and the patients' quality of life?
Participants will:
* Take cabozantinib according to either the experimental or standard dosage regimen for 4 weeks
* After 4 weeks: visit the clinic to collect some blood samples and complete two questionnaires.
* 1 and 3 days after this visit: visit the clinic to collect 1 blood sample.
* The day after the hospital visit: switch to the other dosing regimen and according to that regimen for another 4 weeks.
* After 4 weeks: visit the clinic to collect some blood samples and complete two questionnaires
* 1 and 3 days after this visit: visit the clinic to collect 1 blood sample.
Detailed Description:
Standard regimens: 20 or 40mg once daily with standard breakfast
Experimental regimens:
* Instead of 20mg once daily: 60mg for one day, followed by two skipping days (60-0-0). Also taken with standard breakfast.
* Instead of 40mg once daily: 60mg for two days, followed by one skipping day (60-60-0). Also taken with standard breakfast.
Experimental regimens:
* Instead of 20mg once daily: 60mg for one day, followed by two skipping days (60-0-0). Also taken with standard breakfast.
* Instead of 40mg once daily: 60mg for two days, followed by one skipping day (60-60-0). Also taken with standard breakfast.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-522962-58-00 | CTIS | None | View |