Status: Trial in preparation | Marker: NTRK

Title

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3 or ROS1 Gene Rearrangements.

Study Number
NCT02568267
Indication

Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3 or ROS1 gene rearrangement that is predicted to translate into a fusion protein with a functional TrkA/B/C or ROS1 kinase domain, respectively, without a concomitant second oncodriver (e.g., EGFR, KRAS). These are patients for whom no alternative effective standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.

Primary objective

To determine the objective response rate (ORR) of entrectinib, as assessed by BICR, in each patient population basket of solid tumors that harbor an NTRK1/2/3 or ROS1 gene rearrangement.

In- and exclusion Criteria

• Prior anticancer therapy is allowed (excluding approved or investigational Trk or ROS1 inhibitors in patients who have tumors that harbor those respective gene rearrangements).
• At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy, respectively, at the time of the start of entrectinib treatment.
• Incomplete recovery from any surgery prior to the start of entrectinib treatment that would interfere with the determination of safety or efficacy of entrectinib.

Study design
phase II, open label
Responsibilities

Sponsor Ignyta
Ignyta, Inc.
11111 Flintkote Avenue
San Diego, CA 92121

Trial Centre

Unversity Hospital of Cologne
Department I for Internal Medicince
phone: +49 221 478 87008
fax : +49 221 478 87010
lungenkrebs@uk-koeln.de

Principal investigator

Prof. J. Wolf

Last Update: 5. January 2018