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Trial record 1 of 1 for:    NCT02653989
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Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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ClinicalTrials.gov Identifier: NCT02653989
Recruitment Status : Withdrawn
First Posted : January 13, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 13, 2016
Last Update Posted Date November 25, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
Best overall response rate [ Time Frame: no later than 6 months after the last patient is enrolled in a cohort ]
Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Duration of response (for responders) [ Time Frame: no later than 6 months after the last patient is enrolled in a cohort ]
    Defined as the time from the first objective evidence of CR or PR as assessed by the IRC to the first objective evidence of disease progression or death due to any cause, whichever occurs first.
  • Progression-free survival [ Time Frame: no later than 6 months after the last patient is enrolled in a cohort ]
    Defined as the time from the date of first study drug infusion to the first objective evidence of disease progression or death due to any cause, whichever occurs first.
  • Time to response (for responders) [ Time Frame: no later than 6 months after the last patient is enrolled in a cohort ]
    Defined as the time from the date of first study drug infusion to the first objective evidence of CR or PR as assessed by the IRC.
  • Overall survival [ Time Frame: no later than 6 months after the last patient is enrolled in a cohort ]
    Defined as the time from the date of first study drug infusion to death due to any cause.
  • Composite of safety [ Time Frame: no later than 6 months after the last patient is enrolled in a cohort ]
    Safety will be evaluated by incidence and severity of adverse events, including serious adverse events and incidence of permanent treatment discontinuation due to adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of MDV9300 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official Title  ICMJE An International, Phase 2, Open-Label, Efficacy and Safety Study of MDV9300 in Patients With an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B-Cell Lymphoma
Brief Summary

The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.

Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Large B-Cell, Diffuse
  • Primary Mediastinal Large B-cell Lymphoma
  • Transformed Indolent Lymphoma
Intervention  ICMJE Biological: MDV9300
MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
Study Arms  ICMJE Experimental: MDV9300
Intervention: Biological: MDV9300
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 22, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
180
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or older and willing and able to provide informed consent;
  • Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
  • Received prior treatment with a standard anthracycline and therapeutic anti-CD20 monoclonal antibody-based regimen;
  • For transplant-ineligible patients, salvage therapy just prior to MDV9300 treatment must have resulted in a PR or stable disease;
  • For post autologous stem cell transplant (ASCT) patients, salvage therapy plus ASCT just prior to MDV9300 treatment must have resulted in a PR or stable disease;
  • Adequate bone marrow reserve as defined per protocol;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Patients with stable ECOG scores of 2 may be allowed with medical monitor approval.

Exclusion Criteria:

  • Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
  • History of serious autoimmune disease;
  • History of central nervous system involvement of lymphoma;
  • Prior therapy with agents targeting immune coinhibitory receptors.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653989
Other Study ID Numbers  ICMJE MDV9300-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medivation, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP