Trial | NCT01689220  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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).
Study Started
Sep 30
2012
Primary Completion
Jan 31
2014
Study Completion
Sep 30
2014
Last Update
Sep 04
2014
Estimate

Drug SP-02L (darinaparsin for injection)

Cohort 1: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.

Drug SP-02L (darinaparsin for injection)

Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.

SP-02L Experimental

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
No Results Posted