NCT02737202: SLAM-2

Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis

Terminated Phase 2 Last updated 28 July 2020

What this trial tests

Phase 2 trial testing saracatinib in Pulmonary Lymphangioleiomyomatosis in 28 participants. Terminated before completion.

Timeline

1 April 2016

Primary endpoint
30 July 2019

30 July 2019

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 April 2016
Primary completion	30 July 2019
Estimated completion	30 July 2019
Sites	5 locations across United States

Drugs / interventions tested

• saracatinib — full drug profile →

Conditions studied

• Pulmonary Lymphangioleiomyomatosis — all drugs for Pulmonary Lymphangioleiomyomatosis →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 65, female only, with Pulmonary Lymphangioleiomyomatosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• FEV1
  Time frame: 9 months

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Saracatinib is an efficacious clinical candidate for fibrodysplasia ossificans progressiva.
   Williams E, Bagarova J, Kerr G, Xia DD, et al · · 2021 · cited 55× · PMID 33705358 · DOI 10.1172/jci.insight.95042
2. New insights in lymphangioleiomyomatosis and pulmonary Langerhans cell histiocytosis.
   Torre O, Elia D, Caminati A, Harari S. · · 2017 · cited 26× · PMID 28954765 · DOI 10.1183/16000617.0042-2017
3. The Importance of Tyrosine Phosphorylation Control of Cellular Signaling Pathways in Respiratory Disease: pY and pY Not.
   Aschner Y, Downey GP. · · 2018 · cited 19× · PMID 29812954 · DOI 10.1165/rcmb.2018-0049tr
4. Challenges and Opportunities for Drug Repositioning in Fibrodysplasia Ossificans Progressiva.
   Ventura F, Williams E, Ikeya M, Bullock AN, et al · · 2021 · cited 13× · PMID 33669809 · DOI 10.3390/biomedicines9020213
5. Possible Novel Therapeutic Targets in Lymphangioleiomyomatosis Treatment.
   Song X, Cai H, Yang C, Xue X, et al · · 2020 · cited 11× · PMID 33072782 · DOI 10.3389/fmed.2020.554134
6. Novel treatment strategies for lymphangioleiomyomatosis: a narrative review.
   Elia D, Harari S, Fan L, Diesler R, et al · · 2025 · cited 3× · PMID 40769537 · DOI 10.1183/16000617.0019-2025
7. Lymphangioleiomyomatosis and mTOR inhibitors in real world-a narrative review.
   Park S, Lee EJ. · · 2023 · cited 1× · PMID 38090328 · DOI 10.21037/jtd-23-778