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

Phase 1CompletedNCT01689220
Solasia Pharma K.K.6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

6

Conditions

Peripheral T-cell Lymphoma

Interventions

SP-02L (darinaparsin for injection)DRUG

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.

SP-02L (darinaparsin for injection)DRUG

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.

Eligibility

Sex: ALLMin age: 20 Years
Medical Language ↔ Plain English
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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of dose-limiting toxicity and adverse events

Time frame: 12 or 16 weeks

Secondary Outcomes

Tumor response (overall response)

Time frame: 2 and 4 cycles

Plasma concentration-time profile

Cmax, Area under curve, Tmax, t1/2, Clearance and Volume of distribution

Time frame: 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15

Data from ClinicalTrials.gov

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