Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05770037
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2022-11-24
Brief Title:
DETERMINE Trial Treatment Arm 01 Alectinib in Adult TeenageYoung Adults TYA and Paediatric Patients With ALK Positive Cancers
Sponsor:
Cancer Research UK
Organization:
Cancer Research UK
Study Overview
Official Title:
DETERMINE Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult Paediatric and TeenageYoung Adult TYA Cancers With Actionable Genomic Alterations Including Common Cancers With Rare Actionable Alterations Treatment Arm 01 Alectinib in Adult TeenageYoung Adults TYA and Paediatric Patients With ALK Positive Cancers
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETERMINE
Brief Summary:
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
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
Detailed Description:
DETERMINE Treatment Arm 01 alectinib aims to evaluate the efficacy of alectinib in ALK-positive rare adult paediatric and teenageyoung adult TYA cancers and in common cancers where an ALK mutation or amplification is considered to be infrequent
Rare is defined generally as incidence less than 6 cases in 100000 patients includes paediatric and teenagersyoung 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 where promising activity is identified 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 participant based on molecularly-defined cohorts See information on Master Screening Protocol below
Screening Consenting participants undergo biopsy and collection of blood samples for research purposes
Treatment Participants will receive alectinib until disease progression unacceptable toxicity or withdrawal of consent Participants 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
Rare is defined generally as incidence less than 6 cases in 100000 patients includes paediatric and teenagersyoung 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 where promising activity is identified 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 participant based on molecularly-defined cohorts See information on Master Screening Protocol below
Screening Consenting participants undergo biopsy and collection of blood samples for research purposes
Treatment Participants will receive alectinib until disease progression unacceptable toxicity or withdrawal of consent Participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRAS ID 1004057 | OTHER | IRAS | None |