Trials / Completed
CompletedNCT02579616
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
An Open-Label, Multicenter Phase 2 Study of E7080/ LENVIMA (Lenvatinib Mesylate) in Subjects With Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, single arm, open-label study in participants with unresectable BTC and disease progression or failure following one prior gemcitabine-based doublet chemotherapy regimen (combination of gemcitabine and cisplatin, or gemcitabine and other platinum agent/fluoropyrimidine agent). This study contains 3 phases: a Pre-treatment phase that will last within 21 days; a Treatment phase that will consist of study treatment cycles and tumor assessment conducted every 6-8 weeks; and a Follow-up phase that will begin immediately after the Off-Treatment Visit and will continue as long as the participant is alive, unless the participant withdraws consent, or until the End of Study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Lenvatinib will be administered orally once daily in 28-day cycles. Participants will be treated until disease progression, unacceptable toxicity, withdrawal of consent, participant's choice, etc. |
Timeline
- Start date
- 2015-10-23
- Primary completion
- 2016-11-22
- Completion
- 2019-02-27
- First posted
- 2015-10-19
- Last updated
- 2020-12-23
- Results posted
- 2020-12-23
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02579616. Inclusion in this directory is not an endorsement.