A Phase I, Open Label, Dose Escalation Study of Intravenous Administration of Single Agent NEOD001 in Subjects With Light Chain (AL) Amyloidosis
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 20 additional evaluable subjects.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
Adverse event profile Dose limiting toxicity and maximum tolerated dose
28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator
Yes
Trinh Le
Study Director
Onclave Therapeutics Ltd
United States: Food and Drug Administration
NEOD001-001
NCT01707264
April 2013
September 2016
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Tufts Medical Center | Boston, Massachusetts 02111 |
Stanford University Cancer Center | Stanford, California 94305 |