Back to resultsA Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Primary Purpose
Peripheral T-cell Lymphoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SP-02L (darinaparsin for injection)
SP-02L (darinaparsin for injection)
SP-02L (darinaparsin for injection)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SP-02L
Arm Description
Outcomes
Primary Outcome Measures
Incidence of dose-limiting toxicity and adverse events
Secondary Outcome Measures
Tumor response (overall response)
Plasma concentration-time profile
Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution
Full Information
NCT ID
NCT01435863
First Posted
September 13, 2011
Last Updated
August 11, 2015
Sponsor
Solasia Pharma K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01435863
Brief Title
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Official Title
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solasia Pharma K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SP-02L
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SP-02L (darinaparsin for injection)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SP-02L (darinaparsin for injection)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SP-02L (darinaparsin for injection)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicity and adverse events
Time Frame
12 or 16 weeks
Secondary Outcome Measure Information:
Title
Tumor response (overall response)
Time Frame
2 and 4 cycles
Title
Plasma concentration-time profile
Description
Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Nagoya
State/Province
Aichi
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Fukuoka
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
33051668
Citation
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.
Results Reference
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A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
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