clinical trial · NCT03541902

Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma

M.D. Anderson Cancer Center·phase2·active not recruiting·n = 32

Malignant Neoplasms of Urinary TractRenal Cell CarcinomaChromophobe Renal Cell CarcinomaMetastatic Renal Cell CarcinomaPapillary Renal Cell CarcinomaRenal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene FusionsSarcomatoid Renal Cell CarcinomaStage IV Renal Cell Cancer AJCC v8CabozantinibSunitinib Malate

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.

started

May 15, 2018

primary completion

Jul 31, 2027

completion

Jul 31, 2027

last updated

Jan 9, 2026

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.

official title

Cabosun Ii: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma

full record on clinicaltrials.gov ↗

sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol