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

Completed · Phase 1/Phase 2

Conditions studied: Primary Amyloidosis

In brief

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.

Key facts

Study ID

NCT01707264

Run by

Prothena Biosciences Ltd.

People needed

69

Starts

2013-04-01

Expected to finish

2016-08-09

Last updated by the study team

2018-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged ≥18 years;
• ECOG performance status (PS) 0-2;
• Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible);
• Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis;
• Have adequate organ function;
• Ability to understand and willingness to sign informed consent prior to initiation of any study procedures.

You may not qualify if…

• Secondary or familial amyloidosis;
• Life expectancy of < 3 months;
• Symptomatic multiple myeloma;
• Hypersensitivities to other monoclonal antibodies;
• Known HIV infection;
• Women who are lactating;
• Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.

Where it is running

• Stanford University Cancer Center — Palo Alto, California, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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