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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: Completed Phase 1 study of Primary Amyloidosis, sponsored by Prothena Biosciences.
NCT01707264 is a Phase 1 study of Primary Amyloidosis that has completed, run by Prothena Biosciences. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
* Adverse event profile * Dose limiting toxicity and 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 |
What the finished NCT01707264 record still lists
NCT01707264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
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 lists 7 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Primary Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01707264's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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