Cabozantinib + Lu-177 for Neuroendocrine Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHagen Kennecke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The phase I objective of this study is to establish the maximal tolerated dose (MTD) of cabozantinib in 20 mg, 40 mg and 60 mg dose escalation cohorts in combination with Lu-177 dotatate at a standard dose of 7.4 GBq in four (4) 8-week cycles followed by continuation cabozantinib.

Eligibility Criteria

Adults with well-differentiated neuroendocrine tumors who have had prior systemic therapy, including somatostatin analogue therapy. They should be in good physical condition (ECOG 0-2), have adequate organ and marrow function, and not be pregnant or breastfeeding. Participants must agree to use contraception during the study and for 4 months after.

Inclusion Criteria

I previously had PRRT and it worked for at least 18 months before my condition worsened.

My tumor is a type of neuroendocrine tumor that cannot be surgically removed and is growing.

I am 18 years old or older.

+8 more

Exclusion Criteria

I do not have any major health issues like heart problems, serious wounds, or severe liver issues.

I haven't taken any kinase inhibitor medication in the last 2 weeks.

I am currently taking blood thinners.

+9 more

Participant Groups

The trial is testing different doses of Cabozantinib (20 mg, 40 mg, and 60 mg) combined with a standard dose of Lu-177 dotatate given in four cycles over eight weeks each. The goal is to find the highest dose that patients can tolerate without severe side effects.

5Treatment groups

Experimental Treatment

Group I: Cohort 5Experimental Treatment2 Interventions

Cabozantinib 60 mg qd with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 60 mg qd until disease progression.

Group II: Cohort 4Experimental Treatment2 Interventions

Cabozantinib 60 mg qod alternating with 40 mg qod with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 60 mg qd.

Group III: Cohort 3Experimental Treatment2 Interventions

Cabozantinib 40 mg qd with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 40 mg qd.

Group IV: Cohort 2Experimental Treatment2 Interventions

Cabozantinib 40 mg qod alternating with 20 mg qod with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 40 mg qd.

Group V: Cohort 1Experimental Treatment2 Interventions

Cabozantinib 20 mg daily with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 20 mg qd.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cabometyx for: