Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Kewal Asosingh, Ph.D, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01320865
First received: March 18, 2011
Last updated: February 3, 2014
Last verified: February 2014

March 18, 2011
February 3, 2014
August 2010
December 2012   (final data collection date for primary outcome measure)
Measuring circulating markers of Nilotinib affect [ Time Frame: within one year of the end of the study ] [ Designated as safety issue: No ]
We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib.
Same as current
Complete list of historical versions of study NCT01320865 on ClinicalTrials.gov Archive Site
Evaluate effect of Nilotinib on the activation of mast cells. [ Time Frame: within one year of the end of the study ] [ Designated as safety issue: No ]
We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib. We will also look at the proliferation of mast cell progenitors and correlate this to clinical markers used to monitor this disease.
Same as current
Not Provided
Not Provided
 
Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

Patients diagnosed with PAH that are enrolled in the Nilotinib clinical trial. http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension&rank=1

PAH
Not Provided
Subjects with PAH treated with nilotinib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
December 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01320865
Novartis AMN-107
No
Kewal Asosingh, Ph.D, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Kewal Asosingh, Ph.D The Cleveland Clinic
The Cleveland Clinic
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP