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New treatment option for Childhood Cancer
Official title Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
ClinicalTrials.gov ID: NCT06208657
What this study is testing
What is Paxalisib?
Paxalisib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for childhood cancer.
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
- A companion platform trial to test novel targeted agents based on the patient's tumor profile.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 21
You may be able to join if
- Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard...
- Age \<21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type...
- Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair).
- Patients enrolled in a Phase I cohort must have either evaluable or measurable disease.
- Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for...
You likely can't join if
- Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of...
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases...
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal...
- Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Major surgery within 21 days of the first dose of investigational drug. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour...
- Known hypersensitivity to any study drug or component of the formulation.
See the full eligibility criteria
- Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists.
- Age \<21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent/refractory malignancy.
- Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair).
- Patients enrolled in a Phase I cohort must have either evaluable or measurable disease.
- Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type.
- Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of care may be undertaken at the patient's local oncology treatment centre with results transferred to study site for...
- Performance status: Karnofsky performance status (for patients \> 16 years of age) or Lansky play score (for patients ≤ 16 years of age) ≥ 50%.
- Life expectancy ≥ 6 weeks.
- Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrolment.
- Adequate organ function.
- Able to comply with scheduled follow-up and with management of toxicity.
- Females of childbearing potential must have a negative serum or urine pregnancy test.
- Fertile males must agree to use adequate contraception during the study and following completion of treatment.
- Provide a signed and dated informed consent form.
- Patients with symptomatic central nervous system (CNS) primary or metastatic tumours who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS...
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, or malabsorption syndrome) -...
- Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart...
- Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Major surgery within 21 days of the first dose of investigational drug. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumour biopsy and insertion of central venous access devices are not...
- Known hypersensitivity to any study drug or component of the formulation.
- Pregnant or nursing (lactating) females.
- Any other concomitant serious medical condition or organ dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the investigational...
The study team makes the final eligibility decision.
Where it's taking place
- Newcastle, New South Wales, Australia
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Edmonton, Canada
- Montreal, Canada
- Ottawa, Canada
- Toronto, Canada
- Vancouver, Canada
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, 0 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newcastle, New South Wales, Australia; Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; Hobart, Tasmania, Australia; Melbourne, Victoria, Australia and 6 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.