Trial · NCT06381570
Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas
NCT06381570, Early phase 1, Recruiting, Daniel Morgenstern
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas. Trials, record NCT06381570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06381570
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas
- NCT number
- NCT06381570
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 57 participants, estimated
- Lead sponsor
- Daniel Morgenstern
- Conditions
- Low-grade Glioma
- Interventions
- Tovorafenib, Vinblastine
- First posted
- 2024-04-24
- Last updated
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD/RP2D | 2 years | To determine the maximum tolerated dose (MTD/RP2D) of combination of vinblastine + tovorafenib for children with recurrent/progressive LGGs. |
| Primary | Safety and Tolerability | 2 years | To assess safety and tolerability of combination of vinblastine and tovorafenib in pediatric patients with recurrent/progressive LGG through documentation of number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Primary | Overall response rate | 2 years | To determine overall response rate (ORR) of CR, PR and MR in patients with LGG treated with combination of vinblastine + tovorafenib by RANO-LGG criteria. |
| Secondary | Pharmacokinetics (Cmax vinblastine and tovorafenib) | 5 years (to complete analyses) | To characterize pharmacokinetics of tovorafenib and vinblastine in combination in the study population. The following PK parameters will be determined for each agent: Cmax, Tmax, AUC and reported using descriptive summary statistics |
| Secondary | Pharmacokinetics (AUC of vinblastine and tovorafenib) | 5 years (to complete analyses) | To characterize pharmacokinetics of tovorafenib and vinblastine in combination in the study population. The following PK parameters will be determined for each agent: Cmax, Tmax, AUC and reported using descriptive summary statistics |
| Secondary | Progression free survival | 3-year | |
| Secondary | Duration of response | 3 years | DOR for patients with CR, PR or MR based on RANO-LGG criteria |
| Secondary | Clinical Benefit rate | 3 years | CR, PR and MR plus stable disease which lasts a minimum of 24 weeks by RANO-LGG criteria |
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/NCT06381570
GET https://conductscience.org/api/trials/v1/NCT06381570/registered