What is entrectinib studying for ROS1 gene fusion-positive cancers?

Entrectinib is being studied to see if it can treat various rare and common cancers that have a specific genetic change called ROS1 gene fusion. Researchers want to learn if this drug can help patients beyond its current approved uses. The trial is sponsored by Cancer Research UK and is part of a larger program called DETERMINE that tests targeted therapies for rare cancer types.

Who may be eligible for this ROS1 gene fusion-positive cancer clinical trial?

Adults and children with confirmed ROS1 gene fusion-positive cancers other than non-small cell lung cancer may be eligible. Patients must have a body surface area of at least 0.43 m² and be able to undergo biopsies and blood sample collection. Both males and females can participate if they meet the reproductive safety requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this ROS1 gene fusion-positive cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for their travel and related expenses.

Actively Recruiting

Phase 2

Phase 3

All Genders

ID05770544

Study of Entrectinib for Adults, Children, and Young Adults With ROS1 Gene Fusion-Positive Cancers Including Rare and Common Types

Led by Cancer Research UK · Updated on 2025-11-24

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying entrectinib, a drug approved for treating adult patients with non-small cell lung cancer NSCLC that has a ROS1-positive molecular alteration, and for patients aged 12 years and older with solid tumors having specific cancer cell changes. The trial aims to evaluate if entrectinib is effective for other types of cancers with ROS1 gene fusion, including rare adult, pediatric, and teenageyoung adult cancers. This study is part of the DETERMINE program, which investigates targeted therapies matched to rare cancer types or specific mutations. Participants in this trial receive entrectinib orally, with dosing based on body surface area BSA. Adults and pediatric patients with BSA of 1.51 m or more take 600 mg daily, while those with smaller BSA receive adjusted doses ranging from 100 mg to 400 mg. Each treatment cycle lasts 28 days, and patients continue treatment until disease progression, unacceptable side effects, or withdrawal. Before treatment, patients undergo biopsy and blood sample collection for research, and blood samples are also taken during and at the end of treatment. After treatment, participants are followed every 3 months for 2 years. Throughout the study, patients have regular disease assessments up to 24 weeks from treatment start, including evaluations every two cycles and at the end of treatment. Follow-up visits continue quarterly for up to 2 years. Researchers measure outcomes such as objective response, durable clinical benefit, duration of response, progression-free survival, overall survival, and quality of life through questionnaires. Safety monitoring includes tracking serious adverse reactions and side effects related to entrectinib. The total participation can last several years due to ongoing follow-up and monitoring.

CONDITIONS

Brief Title

DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers.

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Confirmed diagnosis of ROS1 gene fusion-positive cancer other than non-small cell lung cancer, verified by next-generation sequencing
Willing and able to undergo fresh tissue biopsy and blood sample collection for research
Body surface area (BSA) of 0.43 m² or greater
Adults (18 years and older) with adequate organ function as defined by laboratory tests
Paediatric patients (under 18 years) with adequate organ function as defined by laboratory tests
Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception or abstinence during and for five weeks after treatment
Male patients with partners of childbearing potential must agree to use barrier contraception or abstinence during and for three months after treatment and refrain from sperm donation

You will not qualify if you...

Female patients who are pregnant, breastfeeding, or planning pregnancy during treatment or within five weeks after last dose
Diagnosis of ROS1 fusion-positive non-small cell lung cancer
Prior treatment with the same drug class unless resistance mechanisms indicate possible benefit
Significant cardiovascular disease including heart failure, recent heart attack, unstable angina, severe valvular heart disease, recent serious arrhythmias, or recent stroke
Patients with baseline prolonged QTc interval or taking medications that prolong QTc
History of risk factors for Torsades de Pointes
Grade 2 or higher peripheral neuropathy
Active infections including HIV unless controlled with specific criteria
Known hypersensitivity to entrectinib or its ingredients
Recent live attenuated vaccine administration or planned need during and after treatment
Inability to swallow entrectinib capsules intact or gastrointestinal diseases affecting absorption
History of significant osteopenia
Any serious concomitant disease or condition posing unacceptable risk or interfering with trial conduct or drug absorption

Research Team

Aida Sarmiento Castro

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study of Entrectinib for Adults, Children, and Young Adults With ROS1 Gene Fusion-Positive Cancers Including Rare and Common Types

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria