Trial · NCT06208657
Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
NCT06208657, Phase 1, Phase 2, Recruiting, Australian & New Zealand Children's Haematology/Oncology Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer. Trials, record NCT06208657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06208657
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
- NCT number
- NCT06208657
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 90 participants, estimated
- Lead sponsor
- Australian & New Zealand Children's Haematology/Oncology Group
- Conditions
- Childhood Cancer, Childhood Solid Tumor, Childhood Brain Tumor, Recurrent Cancer, Refractory Cancer
- Interventions
- Paxalisib, Opdualag, Irinotecan (drug), Temozolomide (TMZ)
- First posted
- 2024-01-17
- Last updated
- 2026-01-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants treated with molecularly-targeted agents in each treatment arm. | 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. |
| Primary | Recommended phase II dose for each treatment arm | 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. |
| Primary | Objective Response Rate (ORR) for each treatment arm. | 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. |
| Secondary | Overall Clinical Benefit Rate (CBR) for each treatment arm | 5 Years | CBR defined as complete response and partial response and stable disease, as measured by RECIST, RAPNO, INRC or RECIL in CAYA participants treated with molecularly-targeted agents. |
| Secondary | Progression Free Survival (PFS) for each treatment arm. | 5 Years | PFS in CAYA participants from initiation of treatment with molecularly-targeted agents to the occurrence of disease progression, as measured by RECIST, RAPNO, INRC or RECIL, or death. |
| Secondary | Incidence of treatment-emergent adverse events for each treatment arm. | 5 Years | Safety and tolerability of molecularly-targeted agents as measured by incidence of treatment-emergent adverse events reported as per CTCAE V5.0 in CAYA participants. |
| Secondary | Maximum Concentration (Cmax) of molecularly-targeted agents for each treatment arm. | 5 Years | Cmax in plasma after the first dose of molecularly-targeted agents in CAYA participants. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06208657
GET https://conductscience.org/api/trials/v1/NCT06208657/registered