drugset / Trial / NCT02080078
A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is to determine the use of theophylline in patients with NSCLC and advanced solid malignancies and whether treatment with theophylline will help lower or diminish the side effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two parts of the study to verify the lowest dose of theophylline that is effective and the highest dose of erlotinib that can be tolerated with theophylline. If this study shows that theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at higher doses without experiencing severe diarrhea.
Timeline
- Start
- 2014-09
- Primary completion
- 2019-03-30
- Completion
- 2019-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | — |
| Subject | Erlotinib | Small molecule | 200 mg | — |
| Subject | Erlotinib | Small molecule | 225 mg | — |
| Subject | Erlotinib | Small molecule | 250 mg | — |
| Subject | Theophylline | Small molecule | 100 mg | — |
| Subject | Theophylline | Small molecule | 150 mg | — |
| Subject | Theophylline | Small molecule | 200 mg | — |