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Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects (NHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519270
Recruitment Status : Suspended
First Posted : August 10, 2015
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Biological: IGN002 Phase 1

Detailed Description:

This open-label, non-randomized, first-in-human Phase 1 study involves two stages:

In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
Study Start Date : December 2015
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Dose Escalation Stage/ Expansion Stage

The Dose-Escalation Stage will employ a modified 3 + 3 cohort design, subjects will receive up to 26 doses of IGN002.

In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the maximum tolerated dose administered weekly in three 8-week cycles.

Biological: IGN002
IGN002 is a monoclonal antibody fusion protein.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL [ Time Frame: Weekly for 6 months ]
    Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the maximum tolerated dose


Secondary Outcome Measures :
  1. To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly [ Time Frame: Weekly for 6 months ]
    Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL)

  2. To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL [ Time Frame: Every 8 weeks for 6 months, then at 1, 3 and 6 months ]
    Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
  • Refractory disease, having failed available therapies
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy > 3 months
  • Adequate organ function

Exclusion Criteria:

  • Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
  • Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
  • Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
  • Radiation therapy within 4 weeks of Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519270


Locations
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United States, California
UCLA
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
The Leukemia and Lymphoma Society
Investigators
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Principal Investigator: John Timmerman University of California, Los Angeles
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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02519270    
Other Study ID Numbers: IGN002-101
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases