ClinicaliQ Trial Snapshot
- DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) – Master Screening Protocol — Recruiting • Phase II • Oncology • NCT05722886.
- What is being tested: DETERMINE evaluates targeted cancer treatments in rare cancers or common cancers with rare genetic mutations identified through routine molecular testing, using a master screening protocol approach to efficiently match patients to mutation-specific therapies.
- Patient eligibility overview: Patients must have a confirmed cancer diagnosis with an identified genetic mutation; eligibility extends across rare cancer types and molecularly-defined subsets of common cancers, with mutations typically identified during standard diagnostic testing.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
DETERMINE is an open-label phase II/III trial. It will look at targeted treatments in rare cancers or common cancers with rare genetic change (mutation). Patients must have a cancer with an identified mutation. This could be found during routine testing or as part of another research programme. The DETERMINE trial will recruit adults, teenagers and children. If a drug is found to benefit a new patient group, the study team will work with the NHS and the Cancer Drugs Funds to see if these drugs can be available for patients…
Eligibility Snapshot
- THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA OUTLINED BELOW AND WITHIN THE SPECIFIC TREATMENT ARM APPENDIX TO WHICH THEY ARE ENROLLED. Core Inclusion Criteria: 1. Any patient (adult patients or children and TYA as defined in each treatment arm appendix) with histologically proven locally advanced or metastatic cancer (solid tumour or haematological malignancy) who has: 1. exhausted (or declined) standard-of-care treatment options. 2. or for whom no effective standard treatment is available. 3. and whose disease has progressed or is refractory. Exceptional circumstances may apply as described in the protocol. 2. Diagnosis of a rare cancer harbouring an actionable genomic alteration, or common cancer types with rare actionable genomic alterations, that has been identified using a validated next-generation sequencing method and for which there is a relevant open treatment arm within the DETERMINE trial. 3. Life expectancy of at least three months. 4. Patients are able to provide written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up. For patients under 16 years old, the parent or legal guardian will be asked to provide written informed consent and the patient will be asked to provide age-appropriate assent (written or verbal, commensurate with age and level…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.