A STUDY OF CANCER POSITIVE FOR TRKA, TRKB, TRKC, ROS1, OR ALK
Research type
Research Study
Full title
A Phase 1/2a, Multicenter, Open-Label Study of Oral RXDX-101 in Adult Patients with Locally Advanced or Metastatic Cancer Confirmed to be Positive for TrkA, TrkB, TrkC, ROS1, or ALK Molecular Alterations
IRAS ID
156970
Contact name
Timothy Yap
Contact email
Sponsor organisation
Ignyta, Inc.
Eudract number
2014-001326-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, days
Research summary
Patients diagnosed with locally advanced or metastatic cancer confirmed to be positive for TRKA, TRKB, TRKC, ROS1, OR ALK molecular alterations, will be invited to participate in this study. The purpose of this research study is to see if the study drug 'Entrectinib (formerly known as RXDX-101), is safe and tolerable (no bad side effects). Study drug comes in capsules of 50 mg, 100 mg, and 200 mg strengths. The dose that patients will take will depend on the patient's body surface area. Treatment with study drug may continue until the patient experiences disease progression, withdraws consent, or experiences unacceptable toxicity. Treatment may continue as long as the Investigator believes the patient continues to derive clinical benefit in the absence of disease progression. There is no limit on the number of cycles a patient can receive. The study will be open label, which means both the patient and the study doctor will know which treatment options the patient is on. The primary objective of the Phase 1 dose escalation segment is to determine safety and tolerability, and a biologically effective and recommended Phase 2 dose (RP2D) of study drug orally administered once or twice daily. The primary objective of the Phase 2a expansion cohorts is efficacy at the RP2D of study drug orally administered once or twice daily.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/0132
Date of REC Opinion
25 Feb 2015
REC opinion
Favourable Opinion