Actively Recruiting
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol
Led by Cancer Research UK · Updated on 2025-11-24
825
Participants Needed
27
Research Sites
343 weeks
Total Duration
On this page
Sponsors
C
Cancer Research UK
Lead Sponsor
U
University of Manchester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 in the future. This clinicaltrials.gov record refers to the Overall Trial Protocol (Master Screening Record), additional records will be added to clinicaltrials.gov for each treatment arm.
CONDITIONS
Official Title
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient (adult, child, or teenager/young adult) with confirmed advanced or metastatic cancer (solid tumour or blood cancer) who has exhausted or declined standard treatments, or has no effective standard treatment available, and whose disease has progressed or is refractory.
- Diagnosis of a rare cancer with an actionable genetic mutation, or common cancers with rare actionable mutations, identified using validated next-generation sequencing and matching an open treatment arm.
- Life expectancy of at least three months.
- Ability to provide written informed consent (or parent/guardian consent and patient assent if under 16) and cooperate with treatment and follow-up.
- Presence of objectively measurable or evaluable disease.
- Willingness to provide a fresh tissue biopsy at baseline and blood samples for research; for blood cancers or neuroblastoma, blood, bone marrow, or lymph node samples may be taken.
- Adequate performance status: ECOG 0-1 (adults), Karnofsky score ≥50% (teenagers/young adults), or Lansky Play Scale ≥50% (<12 years), with some exceptions for stable neurological deficits.
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to specified birth control methods.
- Male patients with partners of childbearing potential must agree to specified birth control methods.
You will not qualify if you...
- Ongoing adverse events of CTCAE Grade 2 or higher from previous cancer treatments, unless clinically stable.
- High medical risk due to non-malignant systemic diseases or uncontrolled infections.
- Pregnant or breastfeeding women, or those planning pregnancy, and male patients with partners planning pregnancy during or after the trial.
- Participation in another interventional clinical trial during this trial (observational trials without investigational treatment may be allowed).
- Use of other anti-cancer therapies outside this trial (except lifelong hormone suppression for prostate cancer).
- Recent radiotherapy (except palliative), chemotherapy, endocrine therapy (except for non-cancer conditions), immunotherapy, or molecular targeted agents within 4 weeks or 5 half-lives before trial entry.
- Rapidly progressing or symptomatically worsening brain metastases; stable treated brain metastases allowed with conditions.
- Any other condition judged by the investigator to be not in the patient's best interest.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TT
Actively Recruiting
3
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Not Yet Recruiting
4
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
5
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
6
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 OQQ
Actively Recruiting
7
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
8
Cardiff Children's Hospital
Cardiff, United Kingdom, CF14 4XW
Not Yet Recruiting
9
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
10
The Beatson Hospital
Glasgow, United Kingdom, G12 OYN
Actively Recruiting
11
Royal Hospital for Children Glasgow
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
12
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
13
Alder Hey Hospital
Liverpool, United Kingdom, L14 5AB
Actively Recruiting
14
University College London Hospital
London, United Kingdom, NW1 2BU
Actively Recruiting
15
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
16
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
17
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
18
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
19
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
20
Great North Children's Hospital
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
21
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
22
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
23
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
24
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
25
Sheffield's Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
26
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
27
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Aida Sarmiento Castro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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