Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Primary Amyloidosis Clinical Trial

Official title:
A Phase 1/2, Open Label, Dose Escalation Study of Intravenous Administration of Single Agent NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Status Completed

Clinical Trial Summary

Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.

Clinical Trial Description

The purpose of the dose escalation phase of the study is to determine the maximum tolerated dose/Phase 2 recommended dose of NEOD001 when given as a single agent intravenously in approximately 30 subjects with AL amyloidosis.

The purpose of the expansion phase of the study is to evaluate the safety, preliminary efficacy and pharmacokinetics of single agent NEOD001 at the maximum tolerated dose/Phase 2 recommended dose in approximately 25 additional evaluable subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01707264
Study type	Interventional
Source	Prothena Therapeutics Ltd.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2013
Completion date	August 9, 2016

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See also
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Completed	`NCT02555969` - Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis
Completed	`NCT00883623` - A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis	Phase 2