Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim
|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: NCT03057418|
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : May 23, 2017
This is an open-label study of safety, tolerability, pharmacokinetics and pharmacodynamics of Auriхim multiple doses in patients with recurrent/ refractory В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade or with follicular lymphoma, as well as in patients non-treated before for В-cell, CD20-positive non-Hodgkin lymphoma of low tumor grade.
The study will be carried out in 4-6 Russian and Belarussian sites. The study will be consisted of screening period, induction (obligatory) phase and supporting (non-obligatory) phase of the investigational therapy and post-treatment follow-up period.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin Lymphoma, Follicular||Drug: Aurixim||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Auriхim Multiple Doses in Patients With Recurrent/Refractory В-cell, CD20-positive Non-Hodgkin Lymphoma of Low Tumor Grade or With Follicular Lymphoma|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Dosage: 125 mg/m2, 250 mg/m2, 375 mg/m2 and 500 mg/m2. Formulation: concentrate for preparation of infusions 500 mg/50 ml and 100 mg/10 ml.
Mode of administration: intravenous.
Administration will be performed once a week during 4-week induction period, and then once per 12 weeks during supporting period, if necessary. Total maximum duration of the investigational therapy - 1 year, during which patients will receive up to 8 infusions of Aurixim.
Other Name: CON-4619
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Up to 24 weeks after the last dose ]The number of patients with treatment-related AEs assessed by CTCAE, abnormal laboratory values and instrumental tests (ECG) that are related to treatment.
- Maximum tolerated dose (MTD) of Aurixim [ Time Frame: at Day 36 after the first dose ]MTD is defined as maximum dose at which DLT occurs in more than 1 patient of 6
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: Up to week 71 ]PK analysis of multiple doses of Aurixim after single and multiple dosage
- CD19+ [ Time Frame: Up to week 71 ]Pharmacodynamics (PD) of multiple doses of Aurixim after single and multiple
- Peak Plasma Concentration (Cmax) [ Time Frame: Up to week 71 ]PK analysis of multiple doses of Aurixim after single and multiple dosage
- Elimination half-life (T1/2) [ Time Frame: Up to week 71 ]PK analysis of multiple doses of Aurixim after single and multiple dosage
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): NCT03057418
|State Budgetary Public Healthcare Institution of the Nizhni Novgorod Region "Hospital of Ambulance of Dzerzhinsk city"|
|Dzerzhinsk, Russian Federation, 606019|
|Federal State Budgetary Institution "National Medical-Surgical Center n.a. N.I.Pirogov" of the Ministry of Health of the Russian Federation|
|Moscow, Russian Federation, 105203|
|Federal State Budgetary Institution "Russian Oncological Scientific Center n.a. N.N.Blokhin" of the Russian Academy of Medical Sciences|
|Moscow, Russian Federation, 115478|