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A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory 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: NCT02653976
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Solasia Pharma K.K.

Tracking Information
First Submitted Date  ICMJE December 25, 2015
First Posted Date  ICMJE January 13, 2016
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE March 25, 2016
Actual Primary Completion Date October 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2016)
Tumor response [ Time Frame: Change from screening period in tumor response assessed at the end of every 3 cycles from the date of first dosing of study drug, and at the end of treatment visit. Duration is approximately 6 months. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2016)
  • Progression-Free Survival [ Time Frame: Change from screening period in tumor response assessed at the end of every 3 cycles from the date of first dosing of study drug, and every 3 months after the end of treatment visit until documented disease progression. Duration is approximately 1 year. ]
  • Overall Survival [ Time Frame: Survival follow-up from the date of first dosing of study drug until the date of death from any cause, assessed up to 2 years. ]
  • Incidence of all adverse events including clinically significant changes in laboratory values and vital sign measurements [ Time Frame: From the date of first dosing of study drug to the completion of all follow-up procedures. Duration is approximately 6 months. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Official Title  ICMJE Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Brief Summary This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral T-Cell Lymphoma
Intervention  ICMJE Drug: SP-02L (darinaparsin for injection)
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Study Arms  ICMJE Experimental: SP-02L (darinaparsin for injection)
Intervention: Drug: SP-02L (darinaparsin for injection)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 23, 2019)
67
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2016)
65
Estimated Study Completion Date  ICMJE July 31, 2021
Actual Primary Completion Date October 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region
  • Patients aged ≥20 years on the date of informed consent
  • Patients with histologically confirmed diagnosis of one of the following:

    • Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
    • Angioimmunoblastic T-cell Lymphoma (AITL)
    • Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)
  • Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease
  • Have at least 1 measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Patients with a life expectancy of at least 3 months as determined by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653976
Other Study ID Numbers  ICMJE SP-02L02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Solasia Pharma K.K.
Study Sponsor  ICMJE Solasia Pharma K.K.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Solasia Pharma K.K.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP