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

• Sponsor: Solasia Pharma K.K. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01689220
• Collaborator: Synex Consulting Korea Ltd. (Other)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral T-cell Lymphoma	Drug: SP-02L (darinaparsin for injection); Drug: SP-02L (darinaparsin for injection)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: SP-02L

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.; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Incidence of dose-limiting toxicity and adverse events [12 or 16 weeks]

Secondary Outcome Measures

1. Tumor response (overall response) [2 and 4 cycles]

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Solasia Pharma K.K.
• Synex Consulting Korea Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Solasia Pharma K.K.
• ClinicalTrials.gov Identifier: NCT01689220
• Other Study ID Numbers: SP-02L03
• First Posted: Sep 21, 2012
• Last Update Posted: Sep 4, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Sep 4, 2014