DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
NCT ID: NCT05770037
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2023-12-18
2029-10-31
Brief Summary
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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.
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Detailed Description
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\*Rare is defined generally as incidence less than 6 cases in 100,000 patients (includes paediatric and teenagers/young adult cancers) or common cancers with rare alterations.
This treatment arm has a target sample size of 30 evaluable patients. Sub-cohorts may be defined and further expanded to a target of 30 evaluable patients each.
The ultimate aim is to translate positive clinical findings to the NHS (Cancer Drugs Fund) to provide new treatment options for rare adult, paediatric and TYA cancers.
OUTLINE:
Pre-screening: The Molecular Tumour Board makes a treatment recommendation for the patient based on molecularly-defined cohorts (See information on Master Screening Protocol below).
Screening: Consenting patients undergo biopsy and collection of blood samples for research purposes.
Treatment: Patients will receive alectinib until disease progression without clinical benefit, unacceptable adverse events (AEs) or withdrawal of consent. Patients will also undergo collection of blood samples at various intervals while receiving treatment and at EoT.
After completion of study treatment, patients are followed up every 3 months for 2 years.
THE DETERMINE TRIAL MASTER (SCREENING) PROTOCOL:
Please see DETERMINE Trial Master (Screening) Protocol record (NCT05722886) for information on the DETERMINE Trial Master Protocol and applicable documents.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm 01: Alectinib
This alectinib treatment arm is for adult, paediatric and teenage/young adult (TYA) patients with ALK-positive cancers.
Alectinib
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.
Interventions
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Alectinib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
B. Women of childbearing potential are eligible, provided that they meet the following criteria:
* Have a negative serum or urine pregnancy test before enrolment and;
* Agree to use one form of highly effective birth control method such as:
I. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \[oral, intravaginal or transdermal\]
II. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
III. intrauterine device (IUD)
IV. intrauterine hormone-releasing system (IUS)
V. bilateral tubal occlusion
VI. vasectomised partner
VII. sexual abstinence
Effective from the first administration of alectinib, throughout the trial and for three months after the last administration of alectinib.
C. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from first administration of alectinib, throughout the trial and for three months after the last administration of alectinib:
* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence.
* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception, as in criterion B, above.
* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.
All male patients must refrain from donating sperm for the same period.
D. Patients must be able and willing to undergo a fresh tissue biopsy. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and/or trephine or lymph node biopsy samples may be taken.
E. Paediatric patients (patients aged \<18 years) must have a body weight ≥40kg.
F. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.
G. PAEDIATRIC PATIENTS (\<18 years): Adequate organ function as per haematological and biochemical indices within the ranges shown below. These measurements should be performed to confirm the patient's eligibility.
Exclusion Criteria
B. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for three months following their last dose of alectinib.
C. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to alectinib. Patients who have previously received crizotinib (Xalkori\^\[®\]) and did not respond, or who responded inadequately or responded adequately and subsequently progressed, are allowed into the trial.
D. History of or radiological evidence of interstitial lung disease and/or pneumonitis. Prior localised radiotherapy related pneumonitis is permitted if resolved and off steroids and asymptomatic for \>6 months.
E. Patients at risk of gastrointestinal (GI) perforation e.g. history of diverticulitis, concomitant use of medicinal product with a recognized risk of GI perforation (unless patient has also been co-prescribed gastric protection).
• Patients who present with a GI primary tumour or metastases to the GI tract may be considered.
F. Patient unable to swallow or tolerate oral medication or any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or following major bowel resection. Paediatric patients will be excluded if they are unable to swallow the capsules, as per the dosing schedule (150 mg dose strength).
G. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), or New York Heart Association (NYHA) class III or IV congestive heart failure.
Patients with a cerebrovascular event (including stroke or transient ischaemic attack \[TIA\]), or cardiovascular event (including acute myocardial infarction \[MI\]), within three months before the first dose of alectinib.
• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of alectinib, and patients with punctate CNS haemorrhages \<3 mm may be considered.
H. History of organ transplantation.
I. Symptomatic bradycardia for age.
J. Known hypersensitivity to alectinib or any of the excipients. See the current alectinib (Alecensa® 150 mg hard capsules) SmPC for the full list.
K. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during alectinib treatment or within six months after the final dose of alectinib.
L. Active hepatitis B or C virus or known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS) related illness. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:
* CD4 count ≥350/μL;
* undetectable viral load;
* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and
* no HIV/AIDS-associated opportunistic infection in the last 12 months.
M. Familial or personal history of congenital bone disorders, bone metabolism alterations or known osteopenia in the patient.
N. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.
ALL
No
Sponsors
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University of Manchester
OTHER
University of Birmingham
OTHER
Royal Marsden NHS Foundation Trust
OTHER
Hoffmann-La Roche
INDUSTRY
Cancer Research UK
OTHER
Responsible Party
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Principal Investigators
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Matthew Krebs, Dr
Role: PRINCIPAL_INVESTIGATOR
The Christie Hospital
Locations
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Belfast City Hospital
Belfast, , United Kingdom
University Hospital Birmingham
Birmingham, , United Kingdom
Birmingham Children's Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Cardiff Children's Hospital
Cardiff, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
The Beatson Hospital
Glasgow, , United Kingdom
Royal Hospital for Children Glasgow
Glasgow, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Alder Hey Hospital
Liverpool, , United Kingdom
University College London Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Great North Children's Hospital
Newcastle, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Sheffield's Children's Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Stefan Symeonides, Dr
Role: primary
Related Links
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Overview of the DETERMINE trial
ClinicalTrials.gov record for DETERMINE Trial Master Screening Protocol (NCT05722886).
Other Identifiers
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IRAS ID: 1004057
Identifier Type: OTHER
Identifier Source: secondary_id
CRUKD/21/004 - Treatment Arm 1
Identifier Type: -
Identifier Source: org_study_id
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