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Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

NCT02013362 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-11-09

No results posted yet for this study

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

  • Peripheral T-cell Lymphoma

Interventions

DRUG

Pralatrexate injection

DIETARY_SUPPLEMENT

Vitamin B12

DIETARY_SUPPLEMENT

Folic Acid

Sponsors & Collaborators

  • Mundipharma K.K.

    lead INDUSTRY

Principal Investigators

  • Kensei Tobinai, MD,PhD · National Cancer Center Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31
Completion
2017-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013362 on ClinicalTrials.gov