DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

Sponsor
Cancer Research UK
Study ID
NCT05770037
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Anaplastic Large Cell Lymphoma
  • Cancer
  • Haematological Malignancy
  • Lymphoma
  • Lymphoproliferative Disorders
  • Malignant Neoplasm
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Neuroblastoma
  • Renal Cell Carcinoma
  • Solid Tumour

Eligibility Criteria

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

Interventions

  • Alectinib — DRUG
    Adult patients will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Paediatric patients with a body weight ≥40 kg and who are able to swallow the capsules, will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.

Study Details

This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Alectinib works in lung cancer patients with a particular mutation in their cancer known as ALK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same mutation. 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
Dec 18, 2023
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 01: Alectinib
    This alectinib treatment arm is for adult, paediatric and teenage/young adult (TYA) patients with ALK-positive cancers.

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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