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

This study is currently recruiting participants.
Verified March 2013 by Solasia Pharma K.K.
Sponsor:
Information provided by (Responsible Party):
Solasia Pharma K.K.
ClinicalTrials.gov Identifier:
NCT01435863
First received: September 13, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Peripheral T-cell Lymphoma
 Drug: SP-02L (darinaparsin for injection)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Solasia Pharma K.K.:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicity and adverse events [ Time Frame: 12 or 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor response (overall response) [ Time Frame: 2 and 4 cycles ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Cmax, Area under Curve, tmax, t1/2, Clearance and Volume of distribution


Estimated Enrollment: 15
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435863

Contacts
Contact: Solasia Pharma clinicaldev@solasia.co.jp

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

No publications provided

Responsible Party: Solasia Pharma K.K.
ClinicalTrials.gov Identifier: NCT01435863     History of Changes
Other Study ID Numbers: SP-02L01
Study First Received: September 13, 2011
Last Updated: March 8, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on June 18, 2013