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

This study has been terminated.
(Part B of the study was terminated early due to a lack of enrollment.)
Information provided by:
AstraZeneca Identifier:
First received: May 7, 2007
Last updated: September 23, 2009
Last verified: September 2009
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 Intervention Phase
Lymphoma NHL Non-Hodgkin Lymphoma Drug: AZD4877 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]

Estimated Enrollment: 44
Study Start Date: April 2007
Study Completion Date: December 2008
Intervention Details:
    Drug: AZD4877
    intravenous infusion administered twice a week for 2 weeks

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
  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 identifier: 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
  More Information Identifier: NCT00471367     History of Changes
Other Study ID Numbers: D2782C00006
Study First Received: May 7, 2007
Last Updated: September 23, 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 processed this record on September 21, 2017