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AlveolitisPhase 1/2NCT00512902

A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic Sclerosis

A Phase 1/2 study testing Imatinib in people with Alveolitis and Systemic Sclerosis, run by University of California, Los Angeles at 1 site 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 is to assess the safety and tolerability of imatinib (gleevec) in subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the treatment of patients with an accelerated… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alveolitis, Systemic Sclerosis
What is being tested?
Imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Aug 2007to Dec 2008
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

  • All patients must fulfill the criteria for SSc by ACR criteria
  • Age of entry into the study ≥ 18 yrs
  • FVC <85% of predicted.
  • Able to complete the 6MWT with a walking distance ≥ 150 m
  • Patients must have dyspnea on exertion (grade ≥ 2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index).
  • SSc for ≤ 10 years, with onset defined as the date of the first non-Raynaud manifestation typical of systemic sclerosis.
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  • Patients may have limited (cutaneous thickening distal but not proximal to elbows and knees, with or without facial involvement) or diffuse (cutaneous thickening proximal to elbows and knees, often involving the chest or abdomen) cutaneous SSc (Medsger 1995).
  • Patients must show some evidence of alveolitis as defined by an HRCT of the lung which shows ground glass opacification as a radiographic marker of "alveolitis" or finely reticulated fibrosis or they must have alveolitis by BAL ( ≥ 3% PMN's or ≥ 2% eosinophils).
  • Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
  • Patients must be able to provide written voluntary informed consent.

Who cannot join

  • FVC ≤ 50% of predicted or DLCO (corrected for Hgb but not for alveolar volume) ≤ 35% of predicted (suggesting severe probably irreparable disease and/or significant pulmonary vascular involvement by SSc).
  • FEV1/FVC ratio <65% (to exclude significant airflow obstruction)
  • Clinically significant abnormalities on HRCT not attributable to SSc (e.g., lung mass, extensive scarring due to previous infection, etc.)
  • Clinically significant pulmonary hypertension documented on right heart catheterization (i.e., right ventricular systolic pressure of >50 mm Hg and/or mean PAP ≥30 mm Hg) pulmonary pressure or echocardiographic evidence of PAH (if echo cardiographic systolic pressure ≥ 55 mmHg) or FVC/DLCO ratio >1.6 on pulmonary function testing
  • Persistent unexplained hematuria (>10 RBCs/hpf).
  • History of persistent leukopenia (white blood cell count <3500), neutropenia (absolute neutrophil count < 1500) or thrombocytopenia (platelet count <100,000).
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  • Clinically significant anemia (<9.0 gm/dl)
  • Serum creatinine >ULN.
  • Pregnancy (documented by urine pregnancy test), breast feeding
  • If of child-bearing potential, failure regularly to employ a reliable means of contraception
  • Active infection of the lung or elsewhere, whose management would be compromised by Imatinib
  • Unreliability, drug abuse (including active alcoholism)
  • Any chronic, debilitating illness (other than SSc)
  • Smoking of cigars, pipes or cigarettes during the past 6 months
  • Baseline liver function tests (ALT or AST or bilirubin >1.5 x upper limit of normal
  • Previous use of prednisone > 10 mg per day. If on prednisone ≤10 mg/d, dose must have been stable for > 1 month.
  • All other medication with putative disease-modifying properties (e.g., D-penicillamine, cyclophosphamide, azathioprine, methotrexate, colchicine, Potaba) must be discontinued 1 month prior to beginning study medication.
  • Patient is < 5 years since she/he had a primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed except after consultation with the PI.
  • Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
  • Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  • Patient has known chronic liver disease (i.e., chronic active hepatitis and cirrhosis).
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  • Use of contraindicated medications at baseline.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA David Geffen School of Medicine, Division of Rheumatology

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis

The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the treatment of patients with an accelerated phase. Imatinib is also approved for the treatment of patients with a certain type of gastrointestinal cancer (called stromal tumors) but it has not been approved to treat systemic sclerosis. Imatinib works by interfering with an enzyme called tyrosine phosphatase resulting in suppression of the immune system. It als interferes with a protein called platelet derived growth factor receptor (PDGFr) that has been linked to increased fibrosis.

Read the detailed description

Systemic sclerosis is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin. In some cases, systemic sclerosis also affects the blood vessels an internal organs. Systemic sclerosis is one of a group of arthritic conditions called connective tissue disorders, a person's antibodies are directed against their own tissues.

Being tested
Imatinib
Keywords
active alveolitis in systemic sclerosis
Medical subject headings
Scleroderma, Systemic

What participants receive

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

  • ImatinibDrug

    Also called Gleevec

    All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg at each visit for the first 12 weeks. Your participation may last up to 1 year and participants will have approximately 18 clinic visits.

  • ImatinibDrug

    Also called Gleevec

    Up to 600 mg QD PO for up to 1 year.

Study groups in NCT00512902
Study groupRoleWhat they receive
Group 1ExperimentalSSc patients receiving Imatinib (Gleevec, up to 600 mg) QD PO for up to 1 year.
Receives: Drug: Imatinib

What is being measured

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

  1. Treatment-related Adverse Events

    Treatment-related adverse events requiring discontinuation.

    Measured: Baseline vs. Endpoint (1 year)

Secondary outcomes (4)

  1. Change in FVC (Forced Vital Capacity)

    Measures the amount of air breathed out as a percent of predicted.

    Measured: Baseline vs. Endpoint (1 year)

  2. Change in TLC (Total Lung Capacity)

    No measures of dispersion was available for TLC as data were lost. This describes the total lung capacity as a percent of predicted.

    Measured: Baseline vs. Endpoint (1 year)

  3. Change in DLco

    DLCO (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) is the extent to which oxygen passes from the air sacs of the lungs into the blood. Commonly, it refers to the test used to determine this parameter.

    Measured: Baseline vs. Endpoint (1 year)

  4. Change in Modified Rodnan Skin Score (MRSS)

    No measures of dispersion was available as data were lost. The range of this measure is 0 to 51 and measures the extent of skin thickening with higher numbers representing thickening.

    Measured: Baseline vs. Endpoint

Timeline

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

  1. First posted8 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionNov 2008
  4. Study completionDec 2008

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00512902
Sponsor's protocol ID
CST1571EUS210
Status last verified
Oct 2014
First submitted
6 Aug 2007
Last updated
27 Oct 2014
Data monitoring committee
No

Publications

  • Khanna D, Saggar R, Mayes MD, Abtin F, Clements PJ, Maranian P, Assassi S, Saggar R, Singh RR, Furst DE. A one-year, phase I/IIa, open-label pilot trial of imatinib mesylate in the treatment of systemic sclerosis-associated active interstitial lung disease. Arthritis Rheum. 2011 Nov;63(11):3540-6. doi: 10.1002/art.30548.

    PubMed 21769849

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Imatinib in people with Alveolitis and Systemic Sclerosis, run by University of California, Los Angeles at 1 site 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 10 inclusion and 23 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 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 27 Oct 2014). 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?

Treatment-related Adverse Events (time frame: Baseline vs. Endpoint (1 year)). 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 NCT00512902, 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 27 Oct 2014.

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