Spots Global Cancer Trial Database for Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
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Trial Identification
Brief Title: Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Official Title: Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Study ID: NCT02013362
Conditions
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan
National Cancer Center Hospital, Chuo, Tokyo, Japan
Okayama University Hospital, Okayama,, , Japan
Contact Details
Name: Kensei Tobinai, MD,PhD
Affiliation: National Cancer Center Hospital
Role: PRINCIPAL_INVESTIGATOR
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