GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
- Registration Number
- NCT01933516
- Lead Sponsor
- Sandoz
- Brief Summary
The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
- Patient with at least one measurable lesion.
- Patient with ECOG performance status 0 or 1.
Exclusion Criteria
- Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
- Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
- Patient who has mAb therapy other than rituximab as prior line of therapy.
- Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
- Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GP2013 GP2013 -
- Primary Outcome Measures
Name Time Method Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013 12 weeks Time to reach maximum concentration of GP2013 12 weeks To evaluate safety of GP2013 12 weeks Adverse events, laboratory abnormalities
Maximum observed concentration of GP2013 12 weeks Minimum (trough) observed concentration during each dosing interval of GP2013 12 weeks Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013 12 weeks Elimination half-life associated with the terminal slope of GP2013 12 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the incidence of immunogenicity (ADA formation) against GP2013 12 weeks Immunogenicity (ADA formation)
To evaluate efficacy of GP2013 12 weeks Antitumor activity
To evaluate peripheral CD19+ B-cell count 12 weeks CD19 + B-cell count
Trial Locations
- Locations (1)
Investigative Site
🇯🇵Tachikawa, Tokyo, Japan