Trials / Unknown
UnknownNCT01929486
Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- Sponsor
- Aichi Medical University · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate safety, pharmacokinetics, effect of regulatory T cell depletion with Mogamulizumab for advanced or recurrent cancer patients.
Detailed description
This study consists of phase Ia and Ib portions for patients with solid tumors. Phase Ia portion is the standard 3+3 dose-escalation design with 0.1mg/kg, 0.5mg/kg and 1.0mg/kg of Mogamulizumab. Phase Ib portion is the randomized study comparing 0.1mg/kg and tolerated dose of Mogamulizumab based on the phase Ia portion to pursue safer and immunologically more efficient dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mogamulizumab | Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week. |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2016-06-01
- First posted
- 2013-08-28
- Last updated
- 2016-02-17
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01929486. Inclusion in this directory is not an endorsement.