Trial record 3 of 39 for:    regeneron | Open Studies

Study of REGN2810 in Patients With Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02651662
First received: January 5, 2016
Last updated: January 7, 2016
Last verified: January 2016
  Purpose
This is an open-label, multicenter, dose escalation study of single-agent REGN2810 in patients with lymphoma. The study treatment period will be from 6 to 12 months, depending on how an individual patient responds to treatment. The follow-up period will be 6 months for all patients.

Condition Intervention Phase
Lymphoma
Drug: REGN2810
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 72 (End of study) ] [ Designated as safety issue: Yes ]
    TEAEs include abnormal laboratory findings and dose limiting toxicities (DLTs)


Secondary Outcome Measures:
  • Pharmacokinetics (PK) of REGN2810 [ Time Frame: Baseline to Week 72 (End of study) ] [ Designated as safety issue: No ]

    PK variables of REGN2810 may include, but are not limited to, the following:

    Area under the concentration-time curve (AUC) over a dosing interval, the peak concentration and last positive (quantifiable) concentration


  • Immunogenicity (anti-REGN2810 antibodies) [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Antitumor activity (includes response evaluation per Cheson criteria) [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: November 2015
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label
Patients will be administered REGN2810 intravenously (IV) every 2 weeks (Q2W)
Drug: REGN2810

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Have documented CD20+ B-cell NHL or documented HL, with active disease that is either not responsive to or relapsed after prior therapy, for whom no standard of care options exists.
  2. Must have at least 1 bi-dimensionally measurable lesion (≥1.5 cm) documented by diagnostic imaging (CT or MRI).
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  4. Life expectancy of at least 6 months
  5. Adequate bone marrow function
  6. Adequate organ function
  7. Willing and able to comply with clinic visits and study-related procedures
  8. Provide signed informed consent

Key Exclusion Criteria:

  1. Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by nonprimary CNS NHL
  2. History of or current relevant CNS pathology
  3. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for iAEs
  4. Prior allogeneic stem cell transplantation
  5. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway), unless benefit was demonstrated
  6. Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
  7. History of hypersensitivity to any compound in the tetracycline antibiotics group
  8. Known hypersensitivity to both allopurinol and rasburicase
  9. Pregnant or breastfeeding women
  10. Continued sexual activity in men or women of childbearing potential who are unwilling to practice adequate contraception during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02651662

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Texas
START South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02651662     History of Changes
Other Study ID Numbers: R1979-ONC-1504 
Study First Received: January 5, 2016
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 04, 2016