A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Phase 1
Completed
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Drug: SP-02L (darinaparsin for injection)
- Registration Number
- NCT01435863
- Lead Sponsor
- Solasia Pharma K.K.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SP-02L SP-02L (darinaparsin for injection) -
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicity and adverse events 12 or 16 weeks
- Secondary Outcome Measures
Name Time Method 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 Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution