Investigative Site
Tachikawa, Tokyo, 190-0014, Japan
NCT Number: NCT01933516
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 1
Tachikawa, Tokyo, 190-0014, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
GP2013
Time frame: 12 weeks
Adverse events, laboratory abnormalities
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Antitumor activity
Time frame: 12 weeks
Immunogenicity (ADA formation)
Time frame: 12 weeks
CD19 + B-cell count
Sandoz
Industry
Phase I Trial to Assess the Safety and Pharmacokinetics of GP2013 Monotherapy Administered Weekly in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
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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