A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea

Phase 1

Completed

• Conditions: Peripheral T-cell Lymphoma
• Interventions: Drug: SP-02L (darinaparsin for injection)

• Registration Number: NCT01689220
• 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 Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Primary Completion: 2014-01
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

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
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
Tumor response (overall response)	2 and 4 cycles

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of