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

Sponsor
Cancer Research UK
Study ID
NCT05770544
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Brain Neoplasms
  • Cancer
  • Glioma
  • Haematological Malignancy
  • Lymphoproliferative Disorders
  • Malignancy
  • Malignant Neoplasm
  • Melanoma
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Solid Tumour

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Entrectinib — DRUG
    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 AEs or withdrawal of consent.

Study Details

This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

Key Dates

First listed
Mar 15, 2023
Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 03
    This entrectinib treatment arm is for adult, paediatric and TYA patients with ROS1 gene fusion-positive malignancies.

Primary Outcome Measure

Objective Response (OR) [ Time Frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment. ]

Central Contacts

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