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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-02L | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-02L (darinaparsin for injection) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity and adverse events | 12 or 16 weeks |
| 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 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33051668 | Derived | Ogura M, Kim WS, Uchida T, Uike N, Suehiro Y, Ishizawa K, Nagai H, Nagahama F, Sonehara Y, Tobinai K. Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea. Jpn J Clin Oncol. 2021 Feb 8;51(2):218-227. doi: 10.1093/jjco/hyaa177. |
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| SP-02L (darinaparsin for injection) | Drug | 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. |
|
| SP-02L (darinaparsin for injection) | Drug | 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. |
|
| Fukuoka |
| Fukuoka |
| Japan |
| Sendai | Miyagi | Japan |
| Tokyo | Japan |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C515055 | darinaparsin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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