Back to resultsGP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
Primary Purpose
Indolent B-cell Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
GP2013
Sponsored by
About this trial
This is an interventional treatment trial for Indolent B-cell Non-Hodgkin's Lymphoma focused on measuring GP2013, Japanese, indolent B-cell non-Hodgkin's lymphoma, biosimilar, CD20, GP13-101
Eligibility Criteria
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.
Sites / Locations
- Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GP2013
Arm Description
Outcomes
Primary Outcome Measures
To evaluate safety of GP2013
Adverse events, laboratory abnormalities
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
Maximum observed concentration of GP2013
Time to reach maximum concentration of GP2013
Minimum (trough) observed concentration during each dosing interval of GP2013
Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
Elimination half-life associated with the terminal slope of GP2013
Secondary Outcome Measures
To evaluate efficacy of GP2013
Antitumor activity
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
Immunogenicity (ADA formation)
To evaluate peripheral CD19+ B-cell count
CD19 + B-cell count
Full Information
NCT ID
NCT01933516
First Posted
August 8, 2013
Last Updated
July 24, 2018
Sponsor
Sandoz
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01933516
Brief Title
GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
Collaborators
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent B-cell Non-Hodgkin's Lymphoma
Keywords
GP2013, Japanese, indolent B-cell non-Hodgkin's lymphoma, biosimilar, CD20, GP13-101
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GP2013
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GP2013
Intervention Description
GP2013
Primary Outcome Measure Information:
Title
To evaluate safety of GP2013
Description
Adverse events, laboratory abnormalities
Time Frame
12 weeks
Title
Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
Time Frame
12 weeks
Title
Maximum observed concentration of GP2013
Time Frame
12 weeks
Title
Time to reach maximum concentration of GP2013
Time Frame
12 weeks
Title
Minimum (trough) observed concentration during each dosing interval of GP2013
Time Frame
12 weeks
Title
Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
Time Frame
12 weeks
Title
Elimination half-life associated with the terminal slope of GP2013
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To evaluate efficacy of GP2013
Description
Antitumor activity
Time Frame
12 weeks
Title
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
Description
Immunogenicity (ADA formation)
Time Frame
12 weeks
Title
To evaluate peripheral CD19+ B-cell count
Description
CD19 + B-cell count
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz K.K.
Organizational Affiliation
Sandoz
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma
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