Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PAH
- Sponsor
- The Cleveland Clinic
- Locations
- 1
- Primary Endpoint
- Measuring circulating markers of Nilotinib affect
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
Brief Summary
The investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.
Investigators
Kewal Asosingh, Ph.D
Associate Staff
The Cleveland Clinic
Eligibility Criteria
Inclusion Criteria
- •This study is a substudy and subjects must be enrolled in the main trial:
- •See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737)
- •http://clinicaltrials.gov/ct2/show/NCT01179737?
Exclusion Criteria
- •Subjects are not enrolled in the main study:
- •See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737)
- •http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension\&rank=1
Outcomes
Primary Outcomes
Measuring circulating markers of Nilotinib affect
Time Frame: within one year of the end of the study
We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib.
Secondary Outcomes
- Evaluate effect of Nilotinib on the activation of mast cells.(within one year of the end of the study)