Trials / Terminated
TerminatedNCT01291784
Anti-TGF-beta Therapy in Patients With Myelofibrosis
Phase I Study of GC1008 in Patients With Primary Myelofibrosis (PMF), Post-polycythemia Vera/Essential Thrombocythemia Related Myelofibrosis (Post-PV/ET MF)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- John Mascarenhas · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Myelofibrosis
- Primary Myelofibrosis
- Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
- Post-essential Thrombocythemia Related Myelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | monoclonal antibody to TGF-beta | starting dose of 1mg/kg intravenous over approximately 1 hour every 4 weeks for a total of 6 doses |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2011-02-08
- Last updated
- 2014-12-08
- Results posted
- 2014-08-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01291784. Inclusion in this directory is not an endorsement.