A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 4, 2014
September 1, 2014
1.3 years
September 14, 2012
September 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of dose-limiting toxicity and adverse events
12 or 16 weeks
Secondary Outcomes (2)
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
Study Arms (1)
SP-02L
EXPERIMENTALInterventions
Cohort 1: 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.
Eligibility Criteria
You may qualify if:
- Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent
- Patients with histologically confirmed diagnosis of the following:
- PTCL, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solasia Pharma K.K.lead
- Synex Consulting Korea Ltd.collaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 33051668DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 21, 2012
Study Start
September 1, 2012
Primary Completion
January 1, 2014
Study Completion
September 1, 2014
Last Updated
September 4, 2014
Record last verified: 2014-09