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

NCT06663072 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-09

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Pancreatic Neuroendocrine Tumor

Interventions

DRUG

Fulvestrant

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.

DRUG

177Lu-DOTATATE

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.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Chih-Yi (Andy) Liao, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06663072 on ClinicalTrials.gov