Clinical trial NCT01933516: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Indolent B-cell Non-Hodgkin's Lymphoma
Keywords: GP2013
Japanese
indolent B-cell non-Hodgkin's lymphoma
biosimilar
CD20
GP13-101
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2013-09-02
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate safety of GP2013
timeFrame: 12 weeks
measure: Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013
timeFrame: 12 weeks
measure: Maximum observed concentration of GP2013
timeFrame: 12 weeks
measure: Time to reach maximum concentration of GP2013
timeFrame: 12 weeks
measure: Minimum (trough) observed concentration during each dosing interval of GP2013
timeFrame: 12 weeks
measure: Terminal elimination rate constant calculated as the slope of the linear regression of the terminal phase of the logarithmic concentration-time profile of GP2013
timeFrame: 12 weeks
measure: Elimination half-life associated with the terminal slope of GP2013
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate efficacy of GP2013
timeFrame: 12 weeks
measure: To evaluate the incidence of immunogenicity (ADA formation) against GP2013
timeFrame: 12 weeks
measure: To evaluate peripheral CD19+ B-cell count
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tachikawa
country: Japan
facility: Investigative Site
state: Tokyo
Study officials:
affiliation: Sandoz
name: Sandoz K.K.
role: STUDY_DIRECTOR
References: