Trials / Completed
CompletedNCT01776411
Phase I/II Clinical Study of Forodesine in Japanese Recurrent/Refractory Peripheral T-cell Lymphoma Patients
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 49 (estimated)
- Sponsor
- Mundipharma K.K. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Phase I portion: To confirm safety and tolerability in recurrent/refractory peripheral T-cell lymphoma patients during repeated oral administration of forodesine 300 mg twice daily (600 mg/day) for 28 days, and determine the recommended dose. Also, to evaluate pharmacokinetics. Phase II portion: To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | forodesine hydrochloride |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2016-03-01
- Completion
- 2017-04-26
- First posted
- 2013-01-28
- Last updated
- 2017-05-11
Locations
21 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01776411. Inclusion in this directory is not an endorsement.