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

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ClinicalTrials.gov Identifier: NCT01689220
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : September 4, 2014
Sponsor:
Collaborator:
Synex Consulting Korea Ltd.
Information provided by (Responsible Party):
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).

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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.




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicity and adverse events [ Time Frame: 12 or 16 weeks ]

Secondary Outcome Measures :
  1. Tumor response (overall response) [ Time Frame: 2 and 4 cycles ]
  2. Plasma concentration-time profile [ Time Frame: 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689220


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Solasia Pharma K.K.
Synex Consulting Korea Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Solasia Pharma K.K.
ClinicalTrials.gov Identifier: NCT01689220    
Other Study ID Numbers: SP-02L03
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin