NCT04276597

Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.

A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Excel Diagnostics and Nuclear Oncology Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET. The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Conditions

• Pulmonary Neuroendocrine Neoplasm
• Pheochromocytoma
• Paraganglioma
• Thymus Carcinoid
• Unknown Primary Tumors
• Neuroendocrine Tumors
• Neuroendocrine Skin Carcinoma
• Neuroendocrine Breast Tumor
• Neuroendocrine Carcinoma Metastatic
• Neuroendocrine Neoplasm of Ovary

Interventions

Type	Name	Description
DRUG	177Lu-DOTATOC	177Lu labeled somatostatin receptors targeting ligand

Timeline

• Start date: 2020-03-04
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2020-02-19
• Last updated: 2023-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study