BridgeMD
New treatment option for Haematological Malignancy
Official title DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
ClinicalTrials.gov ID: NCT05770037
What this study is testing
What is Alectinib?
Alectinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for haematological malignancy.
Also referred to as Alecensa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 01 (ALECTINIB)...
- \ When alectinib-specific inclusion/
You likely can't join if
- or precautions below differ from those specified in the Master Protocol, the alectinib-specific criteria will take precedence. Inclusion Criteria: A...
- 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...
- 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...
- Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the...
See the full eligibility criteria
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 01 (ALECTINIB) OUTLINED BELOW\
- \ When alectinib-specific inclusion/
- or precautions below differ from those specified in the Master Protocol, the alectinib-specific criteria will take precedence. Inclusion Criteria: A. Confirmed diagnosis of an ALK-positive malignancy using an...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Belfast, United Kingdom
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Cardiff, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
- Leicester, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Metropolitan Borough of Wirral, United Kingdom
- Newcastle, United Kingdom
- Oxford, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belfast, United Kingdom; Birmingham, United Kingdom; Bristol, United Kingdom; Cambridge, United Kingdom; Cardiff, United Kingdom; Edinburgh, United Kingdom and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.