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NCT04365179 · ClinicalTrials.gov registry record · Phase 1
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
A Phase 1 study of AML and Advanced MDS, sponsored by Immune System Key.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04365179 is a Phase 1 study of AML and Advanced MDS that is actively recruiting participants, run by Immune System Key. The registered enrollment target is 18 participants, below the 133-participant average among 29 other AML trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04365179, a Phase 1 study of AML and Advanced MDS, is actively recruiting participants, sponsored by Immune System Key.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label Phase 1b study of NEROFE following a traditional 3+3 design to assess safety and to determine the Recommended Phase 2 Dose (RP2D) of NEROFE in patients with MDS or AML. IV NEROFE will be administered three times per week on alternate days. The exact dosage will be determined using the body surface area (BSA) measured on Day 1 of each cycle.
Conditions Studied
Interventions
- DRUG Nerofe
Study Locations (1)
Florida
- University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2025-08-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04365179
The ClinicalTrials.gov registry entry for NCT04365179 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 29 other AML trials with a reported enrollment target (86% lower). The listed sponsor is Immune System Key, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with AML appearing as the primary indexed condition, and to 1 intervention - of which Nerofe is the first listed.
NCT04365179 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04365179 about?
NCT04365179 is a clinical study titled "Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML". This is an open-label Phase 1b study of NEROFE following a traditional 3+3 design to assess safety and to determine the Recommended Phase 2 Dose (RP2D) of NEROFE in patients with MDS or AML. IV NEROFE will be administered three times per week on alternate days. The exact dosage will be determined us...
What is the current status of trial NCT04365179?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-06-18. Estimated completion is 2025-08-30.
What conditions does trial NCT04365179 study?
This clinical trial studies the following conditions: AML, Advanced MDS.
What interventions are being tested in trial NCT04365179?
The interventions under investigation include: Nerofe (DRUG).
Who is sponsoring clinical trial NCT04365179?
This trial is sponsored by Immune System Key, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04365179 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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