STARTRK-2 Open Label Phase 2 of Entrectinib in Solid Tumours
Research type
Research Study
Full 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, ROS1, or ALK Gene Rearrangements Protocol No:RXDX-101-02
IRAS ID
196539
Contact name
Edna Chow Maneval
Contact email
Sponsor organisation
IQVIA
Eudract number
2015-003385-84
Clinicaltrials.gov Identifier
120500, U.S. IND Number
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
This is an open-label, multicenter, global Phase 2 basket or group study of entrectinib(also known as RXDX-101) for the treatment of patients with different types of cancers that share similar types of DNA defect. Non small cell lung cancer (NSCLC) and metastatic colo-rectal cancer (mCRC) will be the main patient populations of interest, but other baskets will enroll other non-NSCLC and non-mCRC solid tumors that also share similar types of DNA defect or damage.
Entrectinib will be administered orally on a continuous daily dosing regimen, at a dose of 600 mg once-daily in repeated 4-week cycles.
Patients will remain on study treatment until disease progression, development of unacceptable adverse events, or withdrawal of consent.
Patients discontinuing study treatment prior to disease progression will be followed up every 8 weeks.
Approximately 30 days after the last dose of entrectinib, participants will have a post treatment safety follow-up with a long term follow up every 3 months.
Safety will be assessed by monitoring of adverse events, blood and urine tests, physical examination, vital signs (blood pressure and pulse) and Electrocardiogram (ECGs).
Tumour assessments (computed tomography (CT) or magnetic resonance imaging (MRI) scans), bone and/or positron emission tomography (PET-CT) scans plus brain scan as applicable, will be performed.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0136
Date of REC Opinion
9 Mar 2016
REC opinion
Further Information Favourable Opinion