NCT02097810: STARTRK-1

Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.

Completed Phase 1 Last updated 9 June 2021

What this trial tests

Phase 1 trial testing Entrectinib in Locally Advanced Solid Tumors in 84 participants. Completed in 2 June 2020.

Timeline

28 July 2014

Primary endpoint
2 June 2020

2 June 2020

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	28 July 2014
Primary completion	2 June 2020
Estimated completion	2 June 2020
Sites	10 locations across United States, South Korea

Drugs / interventions tested

• Entrectinib (entrectinib) — full drug profile →

Conditions studied

• Locally Advanced Solid Tumors — all drugs for Locally Advanced Solid Tumors →
• Metastatic Solid Tumors — all drugs for Metastatic Solid Tumors →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Locally Advanced Solid Tumors or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or more of these targets are present in several different tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment.

Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.

Publications & conference data

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

1. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials.
   Doebele RC, Drilon A, Paz-Ares L, Siena S, et al · · 2020 · cited 1202× · PMID 31838007 · DOI 10.1016/s1470-2045(19)30691-6
2. NTRK fusion-positive cancers and TRK inhibitor therapy.
   Cocco E, Scaltriti M, Drilon A. · · 2018 · cited 1049× · PMID 30333516 · DOI 10.1038/s41571-018-0113-0
3. Advances in Risk Classification and Treatment Strategies for Neuroblastoma.
   Pinto NR, Applebaum MA, Volchenboum SL, Matthay KK, et al · · 2015 · cited 676× · PMID 26304901 · DOI 10.1200/jco.2014.59.4648
4. Safety and Antitumor Activity of the Multitargeted Pan-TRK, ROS1, and ALK Inhibitor Entrectinib: Combined Results from Two Phase I Trials (ALKA-372-001 and STARTRK-1).
   Drilon A, Siena S, Ou SI, Patel M, et al · · 2017 · cited 609× · PMID 28183697 · DOI 10.1158/2159-8290.cd-16-1237
5. TRKing down an old oncogene in a new era of targeted therapy.
   Vaishnavi A, Le AT, Doebele RC. · · 2015 · cited 483× · PMID 25527197 · DOI 10.1158/2159-8290.cd-14-0765
6. <i>NTRK</i> gene fusions as novel targets of cancer therapy across multiple tumour types.
   Amatu A, Sartore-Bianchi A, Siena S. · · 2016 · cited 423× · PMID 27843590 · DOI 10.1136/esmoopen-2015-000023
7. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials.
   Drilon A, Siena S, Dziadziuszko R, Barlesi F, et al · · 2020 · cited 369× · PMID 31838015 · DOI 10.1016/s1470-2045(19)30690-4
8. Molecular targeting therapies for neuroblastoma: Progress and challenges.
   Zafar A, Wang W, Liu G, Wang X, et al · · 2021 · cited 291× · PMID 33155698 · DOI 10.1002/med.21750