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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435863
• Other study ID #: SP-02L01
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2011
• Last updated: August 11, 2015
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Solasia Pharma K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, 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 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.
• SP-02L (darinaparsin for injection)
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.
• SP-02L (darinaparsin for injection)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Solasia Pharma K.K.

Country where clinical trial is conducted

Japan, 

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