A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solasia Pharma K.K.
• Collaborator: Synex Consulting Korea Ltd.

Criteria

Inclusion Criteria:

• Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent

• Patients with histologically confirmed diagnosis of the following:

• PTCL, not otherwise specified (PTCL-NOS)

• Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)

• Angioimmunoblastic T-cell Lymphoma (AITL)

• Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)

• Have at least 1 evaluable lesion

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

• Life expectancy of at least 3 months