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NCT01291784 · ClinicalTrials.gov registry record · Phase 1
Anti-TGF-beta Therapy in Patients With Myelofibrosis
A Phase 1 study, sponsored by John Mascarenhas.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01291784: Clinical Trial Phase 1 study, sponsored by John Mascarenhas.
NCT01291784 is a Phase 1 study that was terminated before completion, run by John Mascarenhas. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01291784, a Phase 1 study, was terminated before completion, sponsored by John Mascarenhas.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The investigators propose that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation. This is a novel approach to the treatment of patients with myelofibrosis.
Primary Outcome
To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF). A total of 9 AEs determined by the investigator to be at least possibly related to GC1008 occurred during the study.
Interventions
- BIOLOGICAL monoclonal antibody to TGF-beta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
Why NCT01291784 stopped before completion
NCT01291784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which monoclonal antibody to TGF-beta is the first listed.
NCT01291784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01291784 about?
NCT01291784 is a clinical study titled "Anti-TGF-beta Therapy in Patients With Myelofibrosis". TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The investigators propose that inhibiting the...
What is the current status of trial NCT01291784?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01291784?
The interventions under investigation include: monoclonal antibody to TGF-beta (BIOLOGICAL).
Who is sponsoring clinical trial NCT01291784?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01291784's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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