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Entrectinib for Solid Tumors (STARTRK-NG Trial)
STARTRK-NG Trial Summary
This trial is testing a new cancer treatment in children with solid tumors that have come back or are not responding to other treatments. The treatment targets tumors with specific gene mutations.
STARTRK-NG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTARTRK-NG Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STARTRK-NG Trial Design
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Who is running the clinical trial?
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- I do not have any severe health or mental conditions that could worsen by joining this study.My cancer can be measured or evaluated by specific medical criteria.My disease can be measured or evaluated by specific medical criteria.I have a family or personal history of bone disorders or weak bones.I have not taken any seizure medications that affect enzymes in the last 14 days.I can do most activities and am expected to live at least 4 more weeks.My cancer is advanced, can't be removed by surgery without severe side effects, and has no good treatment options.I have recovered from the side effects of my previous cancer treatments.I am not pregnant, breastfeeding, or planning to become pregnant and agree to use birth control during the study.I agree to use contraception or remain abstinent during and for 3 months after treatment.I have had heart failure symptoms or a low heart pump strength in the last 3 months.My cancer has returned or didn't respond to treatment, and it's not in the brain.My cancer was confirmed by lab tests when diagnosed or at relapse.I have been treated with TRK or ROS1 inhibitors before.My neuroblastoma is only in my bone marrow.I do not have any stomach or intestine problems that affect how drugs are absorbed.I have a diagnosed heart condition known as long QT syndrome.My organs and nervous system are functioning well.I currently have an active infection.My brain tumor has NTRK1/2/3 or ROS1 gene changes.My solid tumor has NTRK1/2/3 or ROS1 gene changes.I am still recovering from recent surgery effects.
- Group 1: Neuroblastoma
- Group 2: CNS tumors harboring- NTRK1/2/3, ROS1, ALK
- Group 3: Extracranial solid tumors harboring NTRK1/2/3,
- Group 4: Non-neuroblastoma, extracranial solid tumors
- Group 5: Any participant unable to swallow capsules
- Group 6: Expansion: CNS tumors harboring NTRK1/2/3, ROS1
- Group 7: Expansion: Extracranial solid tumors harboring NTRK1/2/3, ROS1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What impact is this research intended to have?
"This clinical trial aims to determine the Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules over a 6 month period. The secondary objectives of this study include assessment of TTR using RANO, evaluation of Overall Survival with RECIST v1.1, and measuring PFS through RANO for Cohorts B or E."
Are there any existing studies that analyze CNS tumors with NTRK1/2/3 and ROS1 mutations?
"Currently, 18 clinical trials for Expansion: CNS tumors harboring NTRK1/2/3, ROS1 are in progress with 3 of those studies reaching Phase Three. Although Portland is a hub of research activity surrounding this condition, there are 1,578 locations across the globe conducting related medical experiments."
To which neurological malignancies is Expansion: CNS tumors harboring NTRK1/2/3, ROS1 typically administered?
"Expansion: The use of CNS tumors featuring NTRK1/2/3, ROS1 has been widely adopted as a therapeutic intervention to address various conditions and diseases such as neoplasms, malignant tumours, and solid masses."
What is the maximum number of participants accepted for this research?
"Unfortunately, this clinical trial is no longer recruiting subjects. Initially posted on May 3rd 2016 and last updated October 17th 2022, patients need to look elsewhere if they hope to participate in a medical study. Fortunately there are currently 2645 trials related to tumors (solid) and 18 studies specifically for CNS tumours with NTRK1/2/3 or ROS1 actively enrolling participants."
What are the eligibility criteria for participating in this clinical experiment?
"Eligibility for this trial requires that applicants possess tumors of a solid nature and are between infancy and 18 years old. A total of 68 participants are needed to complete the study."
Are there any vacancies in the research cohort?
"Clinicaltrials.gov reveals that the trial, which was initially posted on May 3rd 2016 and last updated October 17th 2022 is not currently seeking participants. Nonetheless, 2663 other trials are recruiting patients presently."
Is this trial open to elderly individuals?
"This clinical trial will include participants between the ages of infancy and 18. Presently, 356 trials are recruiting patients aged 0-18 whereas 2438 studies target those over 65 years old."
Is this experiment unprecedented in its scope?
"Since 2015, Expansion: CNS tumors harboring NTRK1/2/3, ROS1 has been subject to extensive research. Hoffmann-La Roche sponsored the first trial which was conducted in 2015 with 700 participants and eventually led to Phase 2 drug approval. Presently, 18 studies are ongoing across 482 cities and 54 countries."
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