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

Indolent B-cell Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933516
• Other study ID #: GP13-101
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2018
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Indolent B-cell Non-Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• GP2013
GP2013

Locations

Country	Name	City	State
Japan	Investigative Site	Tachikawa	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety of GP2013	Adverse events, laboratory abnormalities	12 weeks
Primary	Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013		12 weeks
Primary	Maximum observed concentration of GP2013		12 weeks
Primary	Time to reach maximum concentration of GP2013		12 weeks
Primary	Minimum (trough) observed concentration during each dosing interval of GP2013		12 weeks
Primary	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
Primary	Elimination half-life associated with the terminal slope of GP2013		12 weeks
Secondary	To evaluate efficacy of GP2013	Antitumor activity	12 weeks
Secondary	To evaluate the incidence of immunogenicity (ADA formation) against GP2013	Immunogenicity (ADA formation)	12 weeks
Secondary	To evaluate peripheral CD19+ B-cell count	CD19 + B-cell count	12 weeks