GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

July 24, 2018 updated by: Sandoz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Tachikawa, Tokyo, Japan, 190-0014
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GP2013
Drug: GP2013
GP2013

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate safety of GP2013
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks
Maximum observed concentration of GP2013
Time Frame: 12 weeks
12 weeks
Time to reach maximum concentration of GP2013
Time Frame: 12 weeks
12 weeks
Minimum (trough) observed concentration during each dosing interval of GP2013
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks
Elimination half-life associated with the terminal slope of GP2013
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate efficacy of GP2013
Time Frame: 12 weeks
Antitumor activity
12 weeks
To evaluate the incidence of immunogenicity (ADA formation) against GP2013
Time Frame: 12 weeks
Immunogenicity (ADA formation)
12 weeks
To evaluate peripheral CD19+ B-cell count
Time Frame: 12 weeks
CD19 + B-cell count
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Novartis Pharmaceuticals

Investigators

  • Study Director: Sandoz K.K., Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP13-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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