Clinical Trial: Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

Brief Summary: This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

Detailed Summary: This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome:

  • Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: 28 days ]
    Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 days ]
    The dose level at which Dose-Limiting Toxicity (DLT) was recognized was to be regarded as Maximum Tolerated Dose (MTD), and the dose level below MTD by one level was to be regarded as the recommended dose level (when MTD was not reached, 1.0 mg/kg was to be regarded as the recommended dose level) and 3 more subjects were to be newly added to the recommended dose level.
  • Pharmacokinetics-Plasma KW-0761 Concentrations [ Time Frame: 0-7 days post final dose ]
    Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.
  • Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days) [ Time Frame: 0-7 days post final dose ]
    The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.
  • Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2) [ Time Frame: 0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period). ]

    Original Primary Outcome:

    • Safety and tolerability
    • Pharmacokinetics


    Current Secondary Outcome:

    • Antitumor Effect [ Time Frame: 50 days ]
      The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).
    • Time to Progression (TTP) [ Time Frame: Baseline to response ]
      TTP was defined as the period from the day starting the first KW-0761 dosing to the day of PD identification (or the day of death if the subject died before PD was documented). Subjects were to be censored at the time of starting post-treatment, if it was started before PD identification.


    Original Secondary Outcome: Clinical response (time to progression)

    Information By: Kyowa Hakko Kirin Co., Ltd

    Dates:
    Date Received: July 20, 2006
    Date Started: February 2007
    Date Completion:
    Last Updated: October 17, 2012
    Last Verified: October 2012