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

Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689220
• Other study ID #: SP-02L03
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2012
• Last updated: September 3, 2014
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Solasia Pharma K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• SP-02L (darinaparsin for injection)
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.
• SP-02L (darinaparsin for injection)
Cohort 2: 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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Solasia Pharma K.K.	Synex Consulting Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity and adverse events		12 or 16 weeks	Yes
Secondary	Tumor response (overall response)		2 and 4 cycles	No
Secondary	Plasma concentration-time profile	Cmax, Area under curve, Tmax, t1/2, Clearance and Volume of distribution	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	No