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Completed

NCT Number: NCT01933516

GP2013 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigative Site

Tachikawa, Tokyo, 190-0014, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GP2013

Drug

GP2013

Primary outcomes

  1. To evaluate safety of GP2013

    Time frame: 12 weeks

    Adverse events, laboratory abnormalities

  2. Area under the curve calculated from start of dose to the end of the dosing interval (tau) of GP2013

    Time frame: 12 weeks

  3. Maximum observed concentration of GP2013

    Time frame: 12 weeks

  4. Time to reach maximum concentration of GP2013

    Time frame: 12 weeks

  5. Minimum (trough) observed concentration during each dosing interval of GP2013

    Time frame: 12 weeks

  6. 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

  7. Elimination half-life associated with the terminal slope of GP2013

    Time frame: 12 weeks

Secondary outcomes

  1. To evaluate efficacy of GP2013

    Time frame: 12 weeks

    Antitumor activity

  2. To evaluate the incidence of immunogenicity (ADA formation) against GP2013

    Time frame: 12 weeks

    Immunogenicity (ADA formation)

  3. To evaluate peripheral CD19+ B-cell count

    Time frame: 12 weeks

    CD19 + B-cell count

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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