Phase 2
Completed N=31
Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis
Scleroderma
Source: ClinicalTrials.gov NCT00764309 ↗
Enrolled (actual)
31
Serious AEs
22.6%
Results posted
Feb 2012
Primary outcomePrimary: Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs) — 0; 31; 7; 0 Participants
Summary
The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs) |
0; 31; 7; 0; 24; 5 | — |
| PRIMARY Reasons for Discontinuation of Study Treatment |
13; 4; 8; 3; 0; 2 | — |
| PRIMARY Laboratory Test Results Summary of Toxicity: Hematology |
28; 1; 1; 1; 4; 17 | — |
| PRIMARY Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR) |
30; 1; 24; 7; 21; 10 | — |
Eligibility Criteria
Inclusion Criteria
Target Population
- meet American College of Rheumatology (ACR) criteria for scleroderma
- have clinical evidence of active skin disease with a skin score of ≥15
- have had the onset of their first non-Raynaud phenomenon feature of SSc no more than 3 years prior to screening
- have evidence of fibrosing alveolitis (active pulmonary fibrosis) manifested by a forced vital capacity (FVC) between 45% and 80% of predicted normal and/or diffusing capacity (DLCO) between 30% and 70% of predicted normal values
- have an abnormal high resolution Computed tomography (CT) scan of the chest/lungs demonstrating typical ground glass changes of alveolitis with background fibrosis
- have adequate renal function- no evidence of renal crisis in the 2 months prior to enrollment and serum creatinine 450 msec) after electrolytes have been corrected on baseline electrocardiogram
Laboratory Test Findings
- Hgb 2.5 times upper limit of normal
Prohibited Treatments and/or Therapies
- use of other immunosuppressive therapies must be discontinued at enrollment, eg methotrexate, azathioprine, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, cyclosporine
- treatment with any other experimental or investigational drug(s) concurrently or less than 12 weeks prior to study enrollment
- use of anti-fibrotic agents must be discontinued at enrollment, eg colchicine, D-penicillamine, minocycline or Type 1 oral collagen
Data sourced from ClinicalTrials.gov (NCT00764309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.