Trials / Completed
CompletedNCT01111461
Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression
An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 (Lenvatinib) in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the objective response rate (ORR: complete response + partial response \[CR+ PR\]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Lenvatinib 24 mg administered orally, once daily continuously in 28-day cycles to participants with advanced endometrial cancer and disease progression following first-line chemotherapy. Participants continued to receive study drug until disease progression, development of unacceptable toxicity or withdrawal of consent. 'Treatment interruption and subsequent dose reduction' was allowed for participants who experienced lenvatinib-related toxicity. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-05-01
- Completion
- 2015-10-01
- First posted
- 2010-04-27
- Last updated
- 2023-06-22
- Results posted
- 2016-04-18
Locations
78 sites across 8 countries: United States, Belgium, Bulgaria, Hungary, Poland, Romania, Russia, Ukraine
Source: ClinicalTrials.gov record NCT01111461. Inclusion in this directory is not an endorsement.