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NCT05468359 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients
A Phase 1 study of Hepatocellular Carcinoma and Pediatric Cancer, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 2
- Study locations
NCT05468359: Recruiting Phase 1 study of Hepatocellular Carcinoma and Pediatric Cancer, sponsored by St. Jude Children's Research Hospital.
NCT05468359 is a Phase 1 study of Hepatocellular Carcinoma and Pediatric Cancer that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 64 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05468359, a Phase 1 study of Hepatocellular Carcinoma and Pediatric Cancer, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase I/II study to evaluate the safety of combining intravenous (IV) atezolizumab and bevacizumab every three weeks, with daily oral cyclophosphamide and pharmacokinetic (PK)-guided sorafenib in children and adolescent and young adults (AYA) with relapsed or refractory solid malignancies (Part 1), and then evaluate the response rate of this combination in children, AYA with relapsed or refractory fibrolamellar carcinoma (FLC) and other rare solid malignancies (Part 2). Primary Objectives Part 1 * To establish the safety associated with the administration of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory solid tumors * To determine if sorafenib systemic exposure can be successfully targeted to an AUC between 20 and 55 hr·µg/mL by Day 21 of cycle 1 in 60% of evaluable patients, when given in combination with cyclophosphamide, bevacizumab, and atezolizumab in children and AYA with relapsed or refractory solid tumors Part 2 * To evaluate the response rate (CR+PR) of the combination of cyclophosphamide, PK-guided sorafenib, bevacizumab and atezolizumab in children and AYA with relapsed or refractory FLC following two cycles of therapy * To determine if the use of PK-guided sorafenib dosing to maintain a systemic exposure between 20 and 55 reduces the interpatient pharmacokinetic variability of sorafenib and the incidence of sorafenib- induced skin toxicities in children and AYA with relapsed or refractory FLC and other rare solid tumors Parts 1 \& 2 * To determine if the combination of cyclophosphamide, PK-guided sorafenib and atezolizumab will result in increased intratumoral T-cell infiltration of CD8+C45RO+ cells between baseline and following two courses of therapy in pediatric children and AYA with relapsed or refractory solid tumors following two cycles of therapy * To characterize the pharmacokinetics of atezolizumab in combination with cyclophosphamide, PK-gui
Primary Outcome
The number of participants who develop a dose limiting toxicity within the first two cycles of therapy that are at least possibly, probably or definitely attributable to atezolizumab, bevacizumab, sorafenib or cyclophosphamide.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Bevacizumab
- DRUG Atezolizumab
- DRUG Sorafenib
Study Locations (2)
Tennessee
- Methodist Le Bonheur Healthcare - Germantown
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-11-07 |
| Est. Completion | 2037-06 |
| Phase | Phase 1 |
What NCT05468359 shows while recruiting
NCT05468359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (75% lower).
The record links to 6 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT05468359 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05468359 about?
NCT05468359 is a clinical study titled "Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients". This is a phase I/II study to evaluate the safety of combining intravenous (IV) atezolizumab and bevacizumab every three weeks, with daily oral cyclophosphamide and pharmacokinetic (PK)-guided sorafenib in children and adolescent and young adults (AYA) with relapsed or refractory solid malignancies ...
What is the current status of trial NCT05468359?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2022-11-07. Estimated completion is 2037-06.
What conditions does trial NCT05468359 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Pediatric Cancer, Pediatric Solid Tumor, Malignant Solid Tumor, Fibrolamellar Carcinoma.
What interventions are being tested in trial NCT05468359?
The interventions under investigation include: Cyclophosphamide (DRUG), Bevacizumab (DRUG), Atezolizumab (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT05468359?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05468359 being conducted?
This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05468359's enrollment target sits among peer trials
64 75th of 145 higher than 71 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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