Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06663072
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Pancreatic Neuroendocrine Tumor

Eligibility Criteria

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

Interventions

  • Fulvestrant — DRUG
    Safety-Run In: Starting Dose: 500 mg IM on Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses. Dose Expansion: 500 mg IM: Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses.
  • 177Lu-DOTATATE — DRUG
    Safety-Run In: Starting Dose: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 Cycles Dose Expansion:177Lu-DOTATATE7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV: IV dose every 8 weeks for a total of 4 Cycles.

Study Details

This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.

Key Dates

Start date
Dec 13, 2024
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety-Run In
    Safety and tolerability data of the combination treatment from the first 6 patients who complete at least 28 days of safety follow-up after the first dose of combination treatment. If no significant safety issues are identified the study will proceed to Arm 2 (dose expansion).
  • Experimental: Dose-Expansion
    Stage 2 will enroll an additional 13 patients for dose expansion. Fulvestrant and 177Lu-DOTATATE will be given at doses 500 mg IM and 7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
1-855-702-8222
Chih-Yi Liao (PRINCIPAL_INVESTIGATOR)

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By research site
University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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