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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2029

Conditions
Haematological MalignancyMalignancyMalignant NeoplasmLymphoproliferative DisordersNeoplasms by Histologic TypeNeoplasms by SiteCancerBrain NeoplasmsMelanomaGliomaSolid Tumour
Interventions
DRUG

Entrectinib

"Adult and paediatric patients with body surface area (BSA) ≥1.51 m\^2 will receive entrectinib orally at a dose of 600 mg daily dose (three 200 mg capsules per day).~Paediatric patients with BSA \<1.51 m\^2 will receive entrectinib at a dose of 100 mg (BSA=0.43-0.50 m\^2) or 200 mg (BSA=0.51-0.80 m\^2) or 300 mg (BSA=0.81-1.10 m\^2) or 400 mg (BSA=1.11-1.50 m\^2).~Each cycle of treatment will consist of 28 days and patients may continue until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent."

Trial Locations (27)

BT9 7AB

RECRUITING

Belfast City Hospital, Belfast

B15 2TT

RECRUITING

University Hospital Birmingham, Birmingham

Unknown

NOT_YET_RECRUITING

Birmingham Children's Hospital, Birmingham

BS2 8BJ

RECRUITING

Bristol Royal Hospital for Children, Bristol

BS2 8ED

RECRUITING

Bristol Haematology and Oncology Centre, Bristol

CB2 OQQ

RECRUITING

Addenbrooke's Hospital, Cambridge

CF14 2TL

RECRUITING

Velindre Cancer Centre, Cardiff

CF14 4XW

NOT_YET_RECRUITING

Cardiff Children's Hospital, Cardiff

EH4 2XU

RECRUITING

Western General Hospital, Edinburgh

G12 OYN

RECRUITING

The Beatson Hospital, Glasgow

G51 4TF

RECRUITING

Royal Hospital for Children Glasgow, Glasgow

LE1 5WW

RECRUITING

Leicester Royal Infirmary, Leicester

L14 5AB

RECRUITING

Alder Hey Hospital, Liverpool

NW1 2BU

RECRUITING

University College London Hospital, London

SE1 9RT

RECRUITING

Guy's Hospital, London

WC1N 3JH

RECRUITING

Great Ormond Street Hospital, London

M13 9WL

NOT_YET_RECRUITING

Royal Manchester Children's Hospital, Manchester

M20 4BX

RECRUITING

The Christie Hospital, Manchester

CH63 4JY

RECRUITING

Clatterbridge Cancer Centre, Metropolitan Borough of Wirral

NE1 4LP

RECRUITING

Great North Children's Hospital, Newcastle

NE7 7DN

RECRUITING

Freeman Hospital, Newcastle

OX3 7LE

RECRUITING

Churchill Hospital, Oxford

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford

S10 2SJ

RECRUITING

Weston Park Hospital, Sheffield

S10 2TH

RECRUITING

Sheffield's Children's Hospital, Sheffield

SO16 6YD

RECRUITING

Southampton General Hospital, Southampton

SM2 5PT

RECRUITING

The Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of Manchester

OTHER

collaborator

University of Birmingham

OTHER

collaborator

Royal Marsden NHS Foundation Trust

OTHER

collaborator

Hoffmann-La Roche

INDUSTRY

lead

Cancer Research UK

OTHER

NCT05770544 - DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage/Young Adult Patients With ROS1 Gene Fusion-positive Cancers. | Biotech Hunter | Biotech Hunter