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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01435863
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
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)
Study Start Date : September 2011
Primary Completion Date : April 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SP-02L 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.
Drug: 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.
Drug: 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.


Outcome Measures

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


Eligibility Criteria

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

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
Contacts and Locations

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): NCT01435863


Locations
Japan
Nagoya, Aichi, Japan
Sendai, Miyagi, Japan
Fukuoka, Japan
Tokyo, Japan
Sponsors and Collaborators
Solasia Pharma K.K.
More Information

Responsible Party: Solasia Pharma K.K.
ClinicalTrials.gov Identifier: NCT01435863     History of Changes
Other Study ID Numbers: SP-02L01
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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