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SclerodermaPhase 1/2NCT00764309

Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

A Phase 1/2 study testing dasatinib in people with Scleroderma, run by Bristol-Myers Squibb at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scleroderma
What is being tested?
dasatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
13 sitesUnited States
Study dates
Jan 2009to Apr 2011
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • have adequate renal function- no evidence of renal crisis in the 2 months prior to enrollment and serum creatinine < 3 mg/dL
  • for both sexes, must use an acceptable form of birth control
  • age ≥ 18

Who cannot join

  • Clinically significant pleural or pericardial effusion in the previous 12 months: Grade 3 or 4. Patients with recent Grade I or II effusions or peripheral edema will be permitted to enter the study
  • Clinically significant cardiac disease (New York Heart Association Class III or IV) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, cardiomyopathy, or pericardial disease
  • Clinically-significant coagulation or platelet function disorder (eg, known von Willebrand's disease)
  • Abnormal QTcF interval prolonged (> 450 msec) after electrolytes have been corrected on baseline electrocardiogram
  • Laboratory Test Findings
  • Hgb < 10 g/dL; platelet count < 100,000/dL; WBC < 3,000/dL; PMN < 1,000/dL; OR lymphocytes < 350/dL
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  • The presence of any of the following laboratory findings at screening: positive for antibodies to hepatitis C virus; positive for antibodies to hepatitis B surface antigen (HBsAg); serum bilirubin 2 times normal, Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST)> 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University Of Michigan

    Ann Arbor, Michigan, 48106

  • Boston University School Of Medicine

    Boston, Massachusetts, 02118

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University Feinberg School Of Medicine

    Chicago, Illinois, 60611

  • University Of Connecticut Health Center

    Farmington, Connecticut, 06030

  • West Michigan Rheumatology

    Grand Rapids, Michigan, 49546

  • Ucla Division Of Rheumatology

    Los Angeles, California, 90095

  • Umdnj Clinical Research Center

    New Brunswick, New Jersey, 08903

  • Hospital For Special Surgery

    New York, New York, 10021

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: An Open Label Study to Evaluate the Safety of Dasatinib in the Treatment of Scleroderma Pulmonary Interstitial Fibrosis

The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.

Conditions
Scleroderma
Being tested
dasatinib
Medical subject headings
Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasatinibDrug

    Also called Sprycel, BMS 354825

    Tablets, Oral, 100 mg, once daily, 6 months

Study groups in NCT00764309
Study groupRoleWhat they receive
A1ExperimentalNot described
Receives: Drug: dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs)

    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.

    Measured: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years

  2. Reasons for Discontinuation of Study Treatment

    Participants who discontinued the study due to any AEs were recorded.

    Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing.

    Measured: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years

  3. Laboratory Test Results Summary of Toxicity: Hematology

    Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.

    Measured: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years

  4. Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR)

    GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.

    Measured: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionJun 2010
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00764309
Sponsor's protocol ID
CA180-267
Status last verified
Jan 2012
First submitted
1 Oct 2008
Last updated
29 Feb 2012
Data monitoring committee
No

Publications

  • Martyanov V, Kim GJ, Hayes W, Du S, Ganguly BJ, Sy O, Lee SK, Bogatkevich GS, Schieven GL, Schiopu E, Marangoni RG, Goldin J, Whitfield ML, Varga J. Novel lung imaging biomarkers and skin gene expression subsetting in dasatinib treatment of systemic sclerosis-associated interstitial lung disease. PLoS One. 2017 Nov 9;12(11):e0187580. doi: 10.1371/journal.pone.0187580. eCollection 2017.

    PubMed 29121645

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing dasatinib in people with Scleroderma, run by Bristol-Myers Squibb at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs) (time frame: From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00764309, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.

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