Last reviewed · How we verify
NCT06208657
Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
Phase 1/Phase 2 trial testing Paxalisib in Childhood Cancer in 90 participants. Currently enrolling.
1 December 2030
Quick facts
| Lead sponsor | Australian & New Zealand Children's Haematology/Oncology Group |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 10 July 2024 |
| Primary completion | 1 December 2030 |
| Estimated completion | 1 December 2035 |
| Sites | 14 locations across Australia, Canada |
Drugs / interventions tested
- Paxalisib — full drug profile →
- Opdualag (RELATLIMAB-RMBW) — full drug profile →
- Irinotecan (drug) — full drug profile →
- Temozolomide (TMZ) — full drug profile →
Conditions studied
- Childhood Cancer — all drugs for Childhood Cancer →
- Childhood Solid Tumor — all drugs for Childhood Solid Tumor →
- Childhood Brain Tumor — all drugs for Childhood Brain Tumor →
- Recurrent Cancer — all drugs for Recurrent Cancer →
Sponsor
Australian & New Zealand Children's Haematology/Oncology Group — full company profile →
Who can join
Adults 0 to 21, any sex, with Childhood Cancer or Childhood Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants treated with molecularly-targeted agents in each treatment arm.
Time frame: 5 Years
Number of CAYA participants (children, adolescents and young adults) with advanced solid tumours (including CNS tumors and non-Hodgkin lymphomas) where molecular sequencing data was used to allocate treatment arms of molecularly-targeted agents. -
Recommended phase II dose for each treatment arm
Time frame: 3 Years
Recommended phase II dose of a novel single agent or combination treatment in CAYA participants, determined by dose-limiting toxicities reported as per CTCAE V5.0. -
Objective Response Rate (ORR) for each treatment arm.
Time frame: 5 Years
ORR defined as complete response and partial response, as measured by RECIST, RAPNO, INRC or RECIL in CAYA participants treated with molecularly-targeted agents.
Sponsor's own description
A companion platform trial to test novel targeted agents based on the patient's tumor profile.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Paediatric Therapeutic Development Workshop on rhabdoid tumours.
Montiel Equihua C, Molenaar JJ, Areso I, Biegel JA, et al · · 2026 · PMID 41680284 · DOI 10.1038/s41416-026-03348-7 -
Beyond base camp: PI3K/mTOR inhibition for the treatment of pediatric high-grade gliomas.
Duchatel RJ, Savary C, Germon ZP, Riley M, et al · · 2025 · PMID 41626633 · DOI 10.1093/neuonc/noaf163 -
From Sequencing to Survival: The Growing Role of Precision Medicine in Paediatric Oncology.
Trinder SM, Ziegler DS, Lau LMS. · · 2025 · PMID 41015612 · DOI 10.1007/s11523-025-01178-w
Verify or expand the search:
- PubMed search for NCT06208657
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Paxalisib
Trials testing the same drug.
- NCT07447076 — Study of Novel Therapies for Young People With Recurrent/Progressive Atypical Teratoid Rhabdoid Tumor (ATRT) · Phase 2 · not yet recruiting
- NCT07391215 — 5G-PEARL: Paxalisib in Malignant Brain Tumours · Phase 1, PHASE2 · recruiting
- NCT05009992 — Combination Therapy for the Treatment of Diffuse Midline Gliomas · Phase 2 · recruiting
Other recruiting trials for Childhood Cancer
Currently open trials in the same condition.
- NCT06839794 — Effect of Cognitively Challenging Physical Activity on Executive Functions in Pediatric Cancer Patients · NA · recruiting
- NCT06609473 — Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Surviv · NA · recruiting
- NCT06854822 — Siblings to a Child with Cancer: Needs and Pre-loss Grief · recruiting
- NCT06769334 — Preparing for Life and Academics for Young Childhood Cancer Survivors · NA · recruiting
- NCT06053268 — Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors · NA · active not recruiting
Other Australian & New Zealand Children's Haematology/Oncology Group trials
Trials by the same sponsor.
- NCT04897880 — A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06208657 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Australian & New Zealand Children's Haematology/Oncology Group
- Last refreshed: 26 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06208657.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing