Status: Active Trial | Marker: RET

Title

A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)

Study Number

NCT03906331

Indication

Patients with a locally advanced or metastatic solid tumor with RET activation

Primary Objective

To provide access to selpercatinib for patients with locally advanced or metastatic solid tumors with activating RET alterations (and other evidence of RET activation) who are 18 years of age or older.

In- and exclusion Criteria

1. Patients with a locally advanced or metastatic solid tumor with RET activation who are not eligible for an ongoing selpercatinib clinical trial (e.g., for clinical, geographic or financial reasons or due to cohort closure)
2. Patients for whom, in the opinion of the Investigator, there is no comparable or satisfactory alternative authorized medicinal product available to treat the patient’s solid tumor with RET activation

Study Design

EAP

Responsibilities

Loxo Oncology, Inc.
281 Tresser Boulevard, 9th Floor
Stamford CT 06901

Trial Centre

University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
E-Mail: lungenkrebs@uk-koeln.de

Principal investigator

Prof. Dr. Jürgen Wolf

Letzte Änderung: 1. October 2020