Actively Recruiting
DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-Positive Cancers
Led by Cancer Research UK · Updated on 2025-11-24
30
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
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 teenage/young 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 m² 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including biopsy and blood sample collection for research
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive entrectinib orally in 28-day cycles and continue treatment until disease progression without clinical benefit, unacceptable adverse events, or withdrawal of consent. Blood samples are collected at various intervals and at the end of treatment.
Visits every 2 cycles (56 days) for disease assessments and blood sample collection, with additional visits at end of treatment
Duration - Up to 2 years after end of treatment
After treatment ends, participants are followed up every 3 months for 2 years to monitor health and disease status.
Quarterly visits every 3 months for up to 2 years
Trial Site Locations
Total: 27 locations
1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TT
Actively Recruiting
3
Birmingham Children's Hospital
Birmingham, United Kingdom
Not Yet Recruiting
4
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
5
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
6
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 OQQ
Actively Recruiting
7
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
8
Cardiff Children's Hospital
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
9
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
10
The Beatson Hospital
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
11
Royal Hospital for Children Glasgow
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
12
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
13
Alder Hey Hospital
Liverpool, United Kingdom, L14 5AB
Actively Recruiting
14
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
15
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
16
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
17
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
18
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
19
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
20
Great North Children's Hospital
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
21
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
22
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
23
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
24
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
25
Sheffield's Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
26
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
27
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Aida Sarmiento Castro
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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