Peripheral T-cell Lymphoma
Conditions
Brief summary
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).
Interventions
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.
Sponsors
Solasia Pharma K.K.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent * Patients with histologically confirmed diagnosis of the following: * Peripheral T-cell Lymphoma, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity and adverse events | 12 or 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response (overall response) | 2 and 4 cycles | — |
| Plasma concentration-time profile | 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 | Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution |
Countries
Japan
Outcome results
None listed