Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03541902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-09
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Cabosun Ii: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
None
Brief Summary:
The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer.
This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC.
The study doctor can explain how the study drugs are designed to work.
Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.
This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC.
The study doctor can explain how the study drugs are designed to work.
Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed Description:
Study Groups:
If participant is found to be eligible to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is better, the same, or worse than the other.
* If participant is assigned to Group 1, participant will receive cabozantinib.
* If participant is assigned to Group 2, participant will receive sunitinib.
Both participant and the study doctor will know to which group participant has been assigned.
Study Drug Administration:
Each study cycle is 6 weeks.
If participant is in Group 1, participant will take cabozantinib tablets by mouth 1 time a day at about the same time every day while on study with a cup (about 8 ounces) of water. The tablets must be swallowed whole. Participant should not crush or chew them. Participant's dose of cabozantinib must be taken on an empty stomach (participant should not eat for at least 2 hours before and at least 1 hour after participant's dose).
If participant is in Group 2, participant will take sunitinib tablets by mouth 1 time a day on a "4 weeks on/2 weeks off" schedule. This means participant will take sunitinib on Days 1-28 and then participant will not take any drug between Days 29-42. Participant may take the tablets with or without food. Sunitinib tablets should be swallowed whole (participant should not crush or chew them) with at least 1 cup of water.
For all participants, if participant misses a dose, participant may take it as soon as participant remembers as long as it has been less than 12 hours of participant's scheduled dose. If it has been more than 12 hours since participant's missed dose, participant must wait until participant's next dose.
Length of Study:
Participant may continue taking the study drug for as long as the doctor thinks it is in participant's best interest. Participant may no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
Participation in this study will be over after follow-up.
Study Visits:
About 7 days before participant's first dose of study drug, the following tests will be performed. If participant has had them done recently, they may not need to be repeated.
* Participant will have a physical exam.
* Participant will have an EKG.
* Blood (about 3½ teaspoons) will be drawn for routine tests and biomarker testing.
* Urine will be collected for routine tests and to check participant's kidney function.
* If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test within 24 hours before participant can begin to receive the study drug(s).
On Day 1 of Week 1 every 6 weeks after that (Weeks 7, 13, 19, 25, and so on):
* Participant will have a physical exam.
* Blood (about 3½ teaspoons) will be drawn for routine and biomarker testing.
Every 6 weeks:
* Participant will have an EKG.
* Participant will have imaging scans
* Blood (about 2 teaspoons) will be drawn to check participant's thyroid function.
* If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
End-of-Treatment:
About 30 days after participant's last dose of study drug:
* Participant will have a physical exam.
* Participant will have an EKG.
* Blood (about 2½ teaspoons) will be drawn for routine and biomarker testing.
* Urine will be collected for routine tests and to check participant's kidney function.
* If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
If participant has a side effect at the follow-up visit and the doctor thinks it is needed, participant may be asked to continue having follow-up visits until the side effect goes away or becomes stable. This will be discussed with participant.
Long-Term Follow-up:
If participant stopped taking study drug before the disease gets worse, participant will continue to have imaging scans every 6 weeks for the first year, then every 6 months.
A member of the study staff will check up on participant to ask how participant is doing every 3 months after participant's last dose of the study drugs. This could be either a phone call or a review of participant's medical and/or other records. If participant is contacted by phone, the call should only last a few minutes.
If participant is found to be eligible to take part in this study, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is better, the same, or worse than the other.
* If participant is assigned to Group 1, participant will receive cabozantinib.
* If participant is assigned to Group 2, participant will receive sunitinib.
Both participant and the study doctor will know to which group participant has been assigned.
Study Drug Administration:
Each study cycle is 6 weeks.
If participant is in Group 1, participant will take cabozantinib tablets by mouth 1 time a day at about the same time every day while on study with a cup (about 8 ounces) of water. The tablets must be swallowed whole. Participant should not crush or chew them. Participant's dose of cabozantinib must be taken on an empty stomach (participant should not eat for at least 2 hours before and at least 1 hour after participant's dose).
If participant is in Group 2, participant will take sunitinib tablets by mouth 1 time a day on a "4 weeks on/2 weeks off" schedule. This means participant will take sunitinib on Days 1-28 and then participant will not take any drug between Days 29-42. Participant may take the tablets with or without food. Sunitinib tablets should be swallowed whole (participant should not crush or chew them) with at least 1 cup of water.
For all participants, if participant misses a dose, participant may take it as soon as participant remembers as long as it has been less than 12 hours of participant's scheduled dose. If it has been more than 12 hours since participant's missed dose, participant must wait until participant's next dose.
Length of Study:
Participant may continue taking the study drug for as long as the doctor thinks it is in participant's best interest. Participant may no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.
Participation in this study will be over after follow-up.
Study Visits:
About 7 days before participant's first dose of study drug, the following tests will be performed. If participant has had them done recently, they may not need to be repeated.
* Participant will have a physical exam.
* Participant will have an EKG.
* Blood (about 3½ teaspoons) will be drawn for routine tests and biomarker testing.
* Urine will be collected for routine tests and to check participant's kidney function.
* If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test within 24 hours before participant can begin to receive the study drug(s).
On Day 1 of Week 1 every 6 weeks after that (Weeks 7, 13, 19, 25, and so on):
* Participant will have a physical exam.
* Blood (about 3½ teaspoons) will be drawn for routine and biomarker testing.
Every 6 weeks:
* Participant will have an EKG.
* Participant will have imaging scans
* Blood (about 2 teaspoons) will be drawn to check participant's thyroid function.
* If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
End-of-Treatment:
About 30 days after participant's last dose of study drug:
* Participant will have a physical exam.
* Participant will have an EKG.
* Blood (about 2½ teaspoons) will be drawn for routine and biomarker testing.
* Urine will be collected for routine tests and to check participant's kidney function.
* If participant can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.
If participant has a side effect at the follow-up visit and the doctor thinks it is needed, participant may be asked to continue having follow-up visits until the side effect goes away or becomes stable. This will be discussed with participant.
Long-Term Follow-up:
If participant stopped taking study drug before the disease gets worse, participant will continue to have imaging scans every 6 weeks for the first year, then every 6 months.
A member of the study staff will check up on participant to ask how participant is doing every 3 months after participant's last dose of the study drugs. This could be either a phone call or a review of participant's medical and/or other records. If participant is contacted by phone, the call should only last a few minutes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: