Trials / Completed
CompletedNCT02013362
Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Mundipharma K.K. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Phase I portion: To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. 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 | Pralatrexate injection | |
| DIETARY_SUPPLEMENT | Vitamin B12 | |
| DIETARY_SUPPLEMENT | Folic Acid |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2015-12-01
- Completion
- 2017-09-01
- First posted
- 2013-12-17
- Last updated
- 2017-11-09
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02013362. Inclusion in this directory is not an endorsement.