Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL
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|ClinicalTrials.gov Identifier: NCT00355472|
Recruitment Status : Completed
First Posted : July 24, 2006
Results First Posted : September 7, 2012
Last Update Posted : October 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Adult T-Cell Leukemia and Lymphoma (ATL) Adult Peripheral T-Cell Lymphoma (PTCL)||Drug: KW-0761||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
IV administration at 4 escalating dose levels.
- 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). ]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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355472
|Study Director:||Study Director||Kyowa Kirin Co., Ltd.|