The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Cohort 1: Darinaparsin 200 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.
Cohort 2: 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.
Cohort 3: 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.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Tokyo, Japan
Incidence of dose-limiting toxicity and adverse events
Time frame: 12 or 16 weeks
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
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