Trials / Completed
CompletedNCT01401530
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | denileukin diftitox (E7777) | E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion. |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2015-08-01
- Completion
- 2016-01-01
- First posted
- 2011-07-25
- Last updated
- 2018-11-23
- Results posted
- 2018-11-23
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01401530. Inclusion in this directory is not an endorsement.