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

Study Overview
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Brief Summary
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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).

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

Conditions
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Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: SP-02L (darinaparsin for injection)
* Drug: SP-02L (darinaparsin for injection)
* Drug: SP-02L (darinaparsin for injection)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-02L<br> | Drug: SP-02L (darinaparsin for injection)<br>* 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.<br>Drug: SP-02L (darinaparsin for injection)<br>* 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.<br>Drug: SP-02L (darinaparsin for injection)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose-limiting toxicity and adverse events |  | 12 or 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response (overall response) |  | 2 and 4 cycles | 
| Plasma concentration-time profile | Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution | 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 |