Actively Recruiting
Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
Led by Australian & New Zealand Children's Haematology/Oncology Group · Updated on 2026-01-28
90
Participants Needed
14
Research Sites
594 weeks
Total Duration
On this page
Sponsors
A
Australian & New Zealand Children's Haematology/Oncology Group
Lead Sponsor
T
The Hospital for Sick Children
Collaborating Sponsor
AI-Summary
What this Trial Is About
A companion platform trial to test novel targeted agents based on the patient's tumor profile.
CONDITIONS
Official Title
Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with a solid tumor, CNS tumor, or lymphoma that has progressed despite standard therapy or has no effective standard therapy.
- Younger than 21 years old at enrollment; patients 21 or older may be included with approval if they have a pediatric-type recurrent/refractory cancer.
- Enrolled in a precision medicine study such as PROFYLE or ZERO, or equivalent.
- Patients in Phase I must have evaluable or measurable disease.
- Patients in Phase II must have measurable disease defined by standard imaging criteria.
- Disease evaluations and tests may be done at local oncology centers with results shared.
- Karnofsky (for >16 years) or Lansky (for ≤16 years) performance status of at least 50%.
- Life expectancy of at least 6 weeks.
- Fully recovered from acute toxic effects of prior anticancer therapy with required minimum time since last treatment.
- Adequate organ function.
- Ability to comply with follow-up and toxicity management.
- Females of childbearing potential must have a negative pregnancy test.
- Fertile males must agree to use contraception during and after treatment.
- Signed and dated informed consent form.
You will not qualify if you...
- Neurologically unstable patients with symptomatic CNS tumors requiring increasing corticosteroids or CNS therapies, unless stable on corticosteroids for at least 7 days.
- Gastrointestinal conditions that affect absorption of oral drugs, for arms with oral treatments.
- Uncontrolled or significant heart disease including arrhythmias, unstable ischemia, or recent heart failure.
- Active viral hepatitis, HIV infection, or uncontrolled infections.
- Major surgery within 21 days before first dose of study drug (minor procedures require 48-hour interval).
- Known allergy to study drugs or their components.
- Pregnant or breastfeeding females.
- Any serious medical condition or organ dysfunction that could compromise safety or study assessment per investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
John Hunter Children's Hospital
Newcastle, New South Wales, Australia
Actively Recruiting
2
Sydney Children's Hospital, Randwick
Sydney, New South Wales, Australia
Actively Recruiting
3
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Actively Recruiting
4
Queensland Children's Hospital
Brisbane, Queensland, Australia
Actively Recruiting
5
Women's and Children's Hospital
Adelaide, South Australia, Australia
Actively Recruiting
6
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
7
Monash Children's Hospital
Melbourne, Victoria, Australia
Actively Recruiting
8
The Royal Children's Hospital
Melbourne, Victoria, Australia
Actively Recruiting
9
Perth Children's Hospital
Perth, Western Australia, Australia
Actively Recruiting
10
Stollery Children's Hospital
Edmonton, Canada
Not Yet Recruiting
11
CHU Sainte Justine
Montreal, Canada
Actively Recruiting
12
Children's Hospital of Eastern Ontario
Ottawa, Canada
Not Yet Recruiting
13
The Hospital for Sick Children
Toronto, Canada
Actively Recruiting
14
BC Children's Hospital
Vancouver, Canada
Actively Recruiting
Research Team
I
International Study Coordinator
CONTACT
I
International Study Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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