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NCT02576496 · ClinicalTrials.gov registry record · Phase 1
Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies
A Phase 1 study of Multiple Myeloma and Cutaneous T Cell Lymphoma, sponsored by Mundipharma Research Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 18
- Study locations
NCT02576496: Completed Phase 1 study of Multiple Myeloma and Cutaneous T Cell Lymphoma, sponsored by Mundipharma Research Limited.
NCT02576496 is a Phase 1 study of Multiple Myeloma and Cutaneous T Cell Lymphoma that has completed, run by Mundipharma Research Limited. The registered enrollment target is 106 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (81% lower). The trial reports 18 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02576496, a Phase 1 study of Multiple Myeloma and Cutaneous T Cell Lymphoma, has completed, sponsored by Mundipharma Research Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 18
- Study locations
Study Summary
This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.
Primary Outcome
Determine overall response rate
Conditions Studied
Interventions
- DRUG Tinostamustine
Study Locations (18)
Other
- CHU de Caen - Caen
- CHU ESTAING Service de thérapie Cellulaire et hématologique Clinique - Clermont-Ferrand
- CHU Lille Service des Maladies du Sang - Lille
- Hopital Haut Leveque - Pessac
- Centre hospitalier Lyon Sud - Pierre-Bénite
- University Hospital of Ulm, Department of Internal Medicine III - Ulm
- Institute of Hematology "L. A. Seràgnoli", University of Bologna - Bologna
- National Cancer Institute, Fondazione 'G. Pascale' - Naples
- VU medisch centrum - Amsterdam
- Erasmus MC - Rotterdam
- Hospital Universitario de Salamanca - Salamanca
- Hospital Universitario Marqués de Valdecilla - Santander
- Kantonsspital St.Gallen - Sankt Gallen
Arizona
- Mayo Clinic - Phoenix
Florida
- Mayo Clinic Cancer Center - Jacksonville
New York
- Columbia University Medical Center - New York
Ohio
- University Hospitals Cleveland Seidman Cancer Center - Cleveland
Barcelona
- Institut Català d'Oncologia de Barcelona - L'Hospitalet de Llobregat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2016-04-14 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 1 |
What the finished NCT02576496 record still lists
NCT02576496 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Tinostamustine is the first listed.
NCT02576496 lists 18 locations in 6 states (Other, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT02576496 about?
NCT02576496 is a clinical study titled "Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies". This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.
What is the current status of trial NCT02576496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2016-04-14. Estimated completion is 2023-11-21.
What conditions does trial NCT02576496 study?
This clinical trial studies the following conditions: Multiple Myeloma, Cutaneous T Cell Lymphoma, Hodgkin's Lymphoma, Hematological Malignancies.
What interventions are being tested in trial NCT02576496?
The interventions under investigation include: Tinostamustine (DRUG).
Who is sponsoring clinical trial NCT02576496?
This trial is sponsored by Mundipharma Research Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02576496 being conducted?
This trial has 18 study locations across Arizona, Florida, New York, Ohio, Barcelona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02576496's enrollment target sits among peer trials
106 160th of 438 higher than 278 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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.
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