Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877

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. Identifier: NCT00471367
Recruitment Status : Terminated (Part B of the study was terminated early due to a lack of enrollment.)
First Posted : May 9, 2007
Last Update Posted : September 24, 2009
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Brief Summary:
This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth

Condition or disease Intervention/treatment Phase
Lymphoma NHL Non-Hodgkin Lymphoma Drug: AZD4877 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma
Study Start Date : April 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Intervention Details:
    Drug: AZD4877
    intravenous infusion administered twice a week for 2 weeks

Primary Outcome Measures :
  1. To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities [ Time Frame: on a twice a week schedule for two weeks out of every three weeks ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification [ Time Frame: assessed after each course of treatment ]
  2. Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma [ Time Frame: Assessed during treatment and post treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Part A: Advanced solid tumors (including lymphoma without bone marrow involvement) for which standard treatment doesn't exist or is no longer effective.
  • Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has relapsed.
  • Relatively good overall health other than your cancer

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function

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 identifier (NCT number): NCT00471367

United States, New York
Research Site
New York, New York, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
Research Site
Greenville, South Carolina, United States
Sponsors and Collaborators
Study Director: Jeffrey Skolnik, MD AstraZeneca
Study Chair: Lea Burke AstraZeneca Identifier: NCT00471367     History of Changes
Other Study ID Numbers: D2782C00006
First Posted: May 9, 2007    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
Phase I
B-cell non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases