Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis

Summary

This study is being done to determine if there is a potential benefit of saracatinib in LAM subjects. Based on the information of this trial, additional clinical development trials will be needed. The study will also test the tolerability of 125 mg of saracatinib given once daily over a 9 month period.

Conditions

• Pulmonary Lymphangioleiomyomatosis

Interventions

DRUG

saracatinib

Subjects will receive enough tablets for 90 days +/- 14 days at each visit. Subject will have visits every 90 days for drug accountability as well as safety and efficacy testing to include pulmonary function testing, laboratory testing to include liver and kidney profile, urine pregnancy testing at each visit, vital signs, physical examination - any medically significant changes from baseline visit will be recorded, all adverse events will be monitored until resolution.

Sponsors & Collaborators

• University of Cincinnati

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Loyola University

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Tony Eissa, MD · Baylor College of Medicine

• Nicola A Hanania, MD · Ben Taub Hospital

• Francis X McCormack, MD · University of Cincinnati

• Daniel Dilling, MD · Loyola University

• Stephen Ruoss, MD · Stanford University

• Joel Moss, MD · Laboratory of Translational Research - NHLBI

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2019-07-30

Completion

2019-07-30

Countries

• United States

Study Locations