OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults
Summary
The study hypothesis is that a lower starting dose of anticancer tablet treatments can lead to better treatment tolerability in older patients, while the benefits of treatment can be the same. The trial population consists of 30 patients aged 65 years or older, who are starting treatment with one of these anti cancer tablet treatments: pazopanib, olaparib, lenvatinib, sunitinib or palbociclib. The control group (half of the participants) will be treated with the standard-of-care, the interventional group will start with the lowest dose of the anti cancer tablets as described in the drug label. The dose will be increased every two weeks in case of good tolerability. Results of this pilot study will be used to inform the design of the larger randomised phase 2 trial.
Timeline
- Start
- 2024-05
- Primary completion
- 2025-03
- Completion
- 2025-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lenvatinib | Small molecule | 10 mg | — |
| Comparator | Lenvatinib | Small molecule | 20 mg | — |
| Comparator | Lenvatinib | Small molecule | 24 mg | — |
| Comparator | Olaparib | Small molecule | 200 mg | — |
| Comparator | Olaparib | Small molecule | 300 mg | — |
| Comparator | Palbociclib | Small molecule | 75 mg | — |
| Comparator | Palbociclib | Small molecule | 125 mg | — |
| Comparator | Pazopanib | Small molecule | 200 mg | — |
| Comparator | Pazopanib | Small molecule | 800 mg | — |
| Comparator | Sunitinib | Small molecule | 25 mg | — |
| Comparator | Sunitinib | Small molecule | 50 mg | — |