GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJuly 26, 2018
July 1, 2018
1.3 years
August 8, 2013
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
To evaluate safety of GP2013
Adverse events, laboratory abnormalities
12 weeks
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
12 weeks
Maximum observed concentration of GP2013
12 weeks
Time to reach maximum 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 Outcomes (3)
To evaluate efficacy of GP2013
12 weeks
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
12 weeks
To evaluate peripheral CD19+ B-cell count
12 weeks
Study Arms (1)
GP2013
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
Investigative Site
Tachikawa, Tokyo, 190-0014, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandoz K.K.
Sandoz
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2013
First Posted
September 2, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
July 26, 2018
Record last verified: 2018-07