Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT05249114
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib tablets are supplied as film coated tablets containing cabozantinib malate equivalent to 20 mg and 60 mg of cabozantinib and contain microcrystalline cellulose, lactose anhydrous, hydoxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and Opadry yellow. The 60 mg tablets are oval and the 20 mg tablets are round. Doses of 40 mg will comprise two 20-mg tablets.
  • Lu-177 — DRUG
    Currently, the only FDA-approved PRRT consists of dotatate, a somatostatin analogue, radiolabeled with Lutetium-177 (Lu177), a beta-minus emitter (brand name Lutathera). Lu177 induces cell death via DNA strand breaks, caspase-3 apoptosis, and interfering with DNA-PK expression (which is associated with DNA repair). PRRT with Lu-177 DOTATATE is a targeted, intravenous therapy inducing DNA damage by delivering ionizing radiation to somatostatin receptor positive tumors.

Study Details

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.

Key Dates

Start date
Dec 28, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Cabozantinib 20 mg daily with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 20 mg qd.
  • Experimental: Cohort 2
    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.
  • Experimental: Cohort 3
    Cabozantinib 40 mg qd with Lu-177 DOTATE administration IV. For cycles 5+, single-agent maintenance of cabozantinib is given at 40 mg qd.
  • Experimental: Cohort 4
    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.
  • Experimental: Cohort 5
    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.

Primary Outcome Measure

Establish the maximal tolerated dose of cabozantinib in combination with Lu-177 dotatae at a standard dose of 7.4 GBg in four 8-week cycles followed by continuation of cabozantinib. [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Cancer Institute - Franz ClinicPortlandOregon97213-

Find similar trials in Portland, OR

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Providence Portland Cancer Institute - Franz Clinic· Portland, OR

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