Entrectinib for Solid Tumors
(STARTRK-2 Trial)
Recruiting at189 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Hoffmann-La Roche
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Research Team
CT
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for adults with advanced solid tumors that have specific gene rearrangements (NTRK1/2/3, ROS1, or ALK). Participants must have measurable disease, may include those with brain involvement if controlled. They should be past certain treatments by at least 2 weeks and have good organ function. People can't join if they've had certain other cancers, bone disorders, heart failure recently, severe neuropathy, active infections or are in another clinical trial.Inclusion Criteria
My cancer can be measured or seen on tests.
Other protocol specified criteria
I finished my radiotherapy more than 14 days ago.
See 9 more
Exclusion Criteria
I have been treated with specific inhibitors for my cancer due to certain gene changes.
I have a family or personal history of bone disorders.
I am still recovering from a recent surgery.
See 9 more
Treatment Details
Interventions
- Entrectinib (Tyrosine Kinase Inhibitor)
Trial OverviewThe study tests Entrectinib's effectiveness on various tumor types with NTRK1/2/3, ROS1 or ALK gene fusions. It's a global Phase 2 trial where patients are grouped based on their tumor type and genetic changes to receive the open-label drug Entrectinib.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: ROS1-rearranged other solid tumorExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group II: ROS1-rearranged mCRCExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group III: ROS1-rearranged NSCLCExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group IV: NTRK1/2/3-rearranged other solid tumorExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group V: NTRK1/2/3-rearranged NSCLCExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group VI: NTRK/1/2/3-rearranged mCRCExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group VII: ALK-rearranged other solid tumorExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group VIII: ALK-rearranged mCRCExperimental Treatment1 Intervention
Oral entrectinib (RXDX-101)
Group IX: ALK- or ROS1-rearranged NSCLCExperimental Treatment1 Intervention
with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.)
Oral entrectinib (RXDX-101)
Entrectinib is already approved in Japan for the following indications:
Approved in Japan as Rozlytrek for:
- Solid tumours with a NTRK gene fusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University