drugset / Trial / NCT03005015
Lenvatinib in Second Line Endometrial Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this multicenter, randomized phase II trial is to assess the efficacy, as measured by progression-free survival (PFS), of lenvatinib compared to doxorubicin in advanced or recurrent endometrial cancer. The main secondary objective is to evaluate the predictive value of Ang-2 on lenvatinib activity and establishing a cutoff value as potential selection criteria for phase III. Other secondary objectives are to assess the tolerability and safety of lenvatinib in this setting and overall survival, response and disease control.
Timeline
- Start
- 2017-01
- Primary completion
- 2020-07
- Completion
- —
Outcome
Outcome not reported
Stopped: “supporting company (Eisai) withdrew their interest”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Lenvatinib | Small molecule | 24 mg | Oral |