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Last Updated: May 23, 2024

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CLINICAL TRIALS PROFILE FOR LUTATHERA


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All Clinical Trials for Lutathera

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01578239 ↗ A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours Completed Pierrel Research Europe GmbH Phase 3 2012-09-06 This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
NCT01578239 ↗ A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours Completed Advanced Accelerator Applications Phase 3 2012-09-06 This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
NCT01876771 ↗ A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours Recruiting AHS Cancer Control Alberta Phase 2 2014-04-29 Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead. The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.
NCT02705313 ↗ EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx Approved for marketing Advanced Accelerator Applications 1969-12-31 Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lutathera

Condition Name

Condition Name for Lutathera
Intervention Trials
Neuroendocrine Tumors 12
Paraganglioma 3
Pheochromocytoma 3
Gastroenteropancreatic Neuroendocrine Tumors 2
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Condition MeSH

Condition MeSH for Lutathera
Intervention Trials
Neuroendocrine Tumors 26
Neoplasms 11
Pancreatic Neoplasms 5
Carcinoid Tumor 4
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Clinical Trial Locations for Lutathera

Trials by Country

Trials by Country for Lutathera
Location Trials
United States 79
Italy 10
France 10
Australia 5
Germany 5
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Trials by US State

Trials by US State for Lutathera
Location Trials
Texas 6
Iowa 6
Minnesota 5
Massachusetts 5
Illinois 5
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Clinical Trial Progress for Lutathera

Clinical Trial Phase

Clinical Trial Phase for Lutathera
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Lutathera
Clinical Trial Phase Trials
Not yet recruiting 19
Recruiting 15
Completed 2
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Clinical Trial Sponsors for Lutathera

Sponsor Name

Sponsor Name for Lutathera
Sponsor Trials
National Cancer Institute (NCI) 12
Advanced Accelerator Applications 11
Novartis Pharmaceuticals 3
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Sponsor Type

Sponsor Type for Lutathera
Sponsor Trials
Other 31
Industry 22
NIH 13
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