AL Amyloidosis Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT01707264

Recruitment Status:

Completed

Sponsor:

Prothena Biosciences Ltd.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

Stanford University Cancer Center
Palo Alto California, 94305, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston University School of Medicine
Boston Massachusetts, 02118, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 1

Estimated Enrollment:

69

Study ID:

NCT01707264

Recruitment Status:

Completed

Sponsor:


Prothena Biosciences Ltd.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider