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Completed

NCT Number: NCT01435863

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

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).

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SP-02L (darinaparsin for injection)

Drug

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.

Primary outcomes

  1. Incidence of dose-limiting toxicity and adverse events

    Time frame: 12 or 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Solasia Pharma K.K.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2011
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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