A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
1 other identifier
interventional
17
1 country
4
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).
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 2011
Longer than P75 for phase_1
4 active sites
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, 2011
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 13, 2015
August 1, 2015
3.6 years
September 13, 2011
August 11, 2015
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 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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Sendai, Miyagi, Japan
Unknown Facility
Tokyo, Japan
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 19, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2015
Study Completion
July 1, 2015
Last Updated
August 13, 2015
Record last verified: 2015-08