The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1)
Lymphangioleiomyomatosis (LAM) is a rare lung disease that mostly affects women of childbearing age. In LAM, abnormal, muscle-like cells begin to grow out of control in the lungs. As a result, air can't move freely in and out of the lungs. In some cases, this means the lungs can't supply the body's other organs with enough oxygen. This study is being conducted to find out what dose of a drug called saracatinib is best tolerated by people with LAM. This drug has been tested in patients with certain types of cancer but is not currently approved by the United States Food and Drug Administration (FDA). Saracatinib may work in cancer by preventing the growth, movement and invasiveness of cancer cells. The use of saracatinib to treat LAM is considered experimental. Preliminary testing already completed suggests that the study drug, saracatinib, may suppress certain substances in the lungs of patients with LAM thus may be effective in slowing down the disease process
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 30, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Tony Eissa
- Interventions being studied
- Drug: Saracatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Male or female patients. It should be noted, however, that LAM occurs predominantly in women.
- 18 to 65 years of age.
- All patients must have a diagnosis of LAM as defined by one of the following: Open lung, transbronchial or thoracic needle biopsy consistent with LAM Open or needle abdominal biopsy findings consistent with LAM Computed tomography (CT) of chest or abdomen consistent with LAM in the setting of TSC, renal angiomyolipoma (AML), cystic abdominal lymphangiomas, or history of chylous effusion in the chest or abdomen CT of chest consistent with LAM plus serum vascular endothelial growth factor (VEGF-D) \> 800 pg/ml In cases where the diagnosis of LAM is based on biopsy, review of the pathology specimens by pathologists who are experienced with LAM, such as those at the NIH or the Mayo Clinic, will be obtained (if not done so previously).
- Current infection.
- Major surgery within the past 2 months
- Advanced hematologic, renal, hepatic, or metabolic diseases
- The use of another investigational drug within 30 days
- The use of mammalian target of rapamycin (mTOR) inhibitors within 30 days
- Previous lung transplantation or active on transplant list.
- Inability to attend scheduled clinic visits
- Inability to give informed consent
- Inability to perform pulmonary function testing
- History of malignancy in the past two years, other than squamous or basal cell skin cancer or mild cervical cancer.
- Nursing mothers
- Current or planned pregnancy.
- Not using adequate contraception (in woman of childbearing potential).
- Significant clinical change in health in the past 30 days
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of CincinnatiCincinnati, Ohio
- Baylor College of MedicineHouston, Texas
- University of Texas Health Science Center-HoustonHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 30, 2016. Always confirm current availability with the study team.