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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Solasia Pharma K.K.
ClinicalTrials.gov Identifier:
NCT01435863
First received: September 13, 2011
Last updated: August 11, 2015
Last verified: August 2015
  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:


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


Enrollment: 17
Study Start Date: September 2011
Study Completion Date: July 2015
Primary Completion Date: April 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 13, 2011
Last Updated: August 11, 2015
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 August 23, 2016