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NCT01707264 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
A Phase 1 study of Primary Amyloidosis, sponsored by Prothena Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 7
- Study locations
NCT01707264 is a Phase 1 study of Primary Amyloidosis that has completed, run by Prothena Biosciences. The registered enrollment target is 69 participants. The trial reports 7 study locations across 6 states.
The verdict
NCT01707264, a Phase 1 study of Primary Amyloidosis, has completed, sponsored by Prothena Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
- 7
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG NEOD001
Study Locations (7)
Massachusetts
- Tufts Medical Center - Boston
- Boston University School of Medicine - Boston
California
- Stanford University Cancer Center - Palo Alto
Michigan
- Karmanos Cancer Institute - Detroit
Minnesota
- Mayo Clinic - Rochester
New York
- Memorial Sloan-Kettering Cancer Center - New York
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-08-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01707264
The ClinicalTrials.gov registry entry for NCT01707264 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prothena Biosciences, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which NEOD001 is the first listed.
NCT01707264 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Massachusetts, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT01707264 about?
NCT01707264 is a clinical study titled "Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis". 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.
What is the current status of trial NCT01707264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2013-04. Estimated completion is 2016-08-09.
What conditions does trial NCT01707264 study?
This clinical trial studies the following conditions: Primary Amyloidosis.
What interventions are being tested in trial NCT01707264?
The interventions under investigation include: NEOD001 (DRUG).
Who is sponsoring clinical trial NCT01707264?
This trial is sponsored by Prothena Biosciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01707264 being conducted?
This trial has 7 study locations across California, Massachusetts, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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