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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.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00471367
First received: May 7, 2007
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00471367

Locations
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
AstraZeneca
Investigators
Study Director: Jeffrey Skolnik, MD AstraZeneca
Study Chair: Lea Burke AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00471367     History of Changes
Other Study ID Numbers: D2782C00006
Study First Received: May 7, 2007
Last Updated: September 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
AZD4877
Lymphoma
B-cell non-Hodgkin lymphoma

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

ClinicalTrials.gov processed this record on November 25, 2014