drugset / Trial / NCT04648033
Atovaquone With Radical ChemorADIotherapy in Locally Advanced NSCLC
Phase 1
Completed
21 enrolled
University of Oxford
Cancer Research UK · collabGuy's and St Thomas' NHS Foundation Trust · collabNHS Lothian · collabNHS Research Scotland · collabNational Institute for Health Research, United Kingdom · collabOxford University Hospitals NHS Trust · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase I, open-label trial that will utilise a Time To Event Continual Reassessment Method (TiTE-CRM) to determine the maximum tolerated dose (MTD) of atovaquone in combination with concurrent CRT in NSCLC. Twenty evaluable participants will be recruited at three centres.
Timeline
- Start
- 2020-12-07
- Primary completion
- 2023-10-02
- Completion
- 2023-10-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atovaquone | Small molecule | 450 mg | Oral |
| Subject | Atovaquone | Small molecule | 600 mg | Oral |
| Subject | Atovaquone | Small molecule | 675 mg | Oral |
| Subject | Atovaquone | Small molecule | 750 mg | Oral |
| Background | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Background | Vinorelbine | Small molecule | 15 mg/m2 | Intravenous |