A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
NCT ID: NCT01435863
Last Updated: 2015-08-13
Study Results
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Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2011-09-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SP-02L
SP-02L (darinaparsin for injection)
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.
SP-02L (darinaparsin for injection)
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)
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.
Interventions
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SP-02L (darinaparsin for injection)
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.
SP-02L (darinaparsin for injection)
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Solasia Pharma K.K.
INDUSTRY
Responsible Party
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Locations
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Nagoya, Aichi-ken, Japan
Fukuoka, Fukuoka, Japan
Sendai, Miyagi, Japan
Tokyo, , Japan
Countries
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References
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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.
Other Identifiers
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SP-02L01
Identifier Type: -
Identifier Source: org_study_id
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