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NCT01770353 · ClinicalTrials.gov registry record · Phase 1
MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
A Phase 1 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01770353: Completed Phase 1 study, sponsored by Ipsen.
NCT01770353 is a Phase 1 study that has completed, run by Ipsen. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01770353, a Phase 1 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
Primary Outcome
Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal chang
Interventions
- DRUG Ferumoxytol
- DRUG MM-398
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-11 |
| Est. Completion | 2018-10-02 |
| Phase | Phase 1 |
What the finished NCT01770353 record still lists
NCT01770353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Ferumoxytol is the first listed.
NCT01770353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01770353 about?
NCT01770353 is a clinical study titled "MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment". This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
What is the current status of trial NCT01770353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2012-11. Estimated completion is 2018-10-02.
What interventions are being tested in trial NCT01770353?
The interventions under investigation include: Ferumoxytol (DRUG), MM-398 (DRUG).
Who is sponsoring clinical trial NCT01770353?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01770353's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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