Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies

This study has been terminated.
(Study was terminated due to low enrollment)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00460460
First received: April 12, 2007
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.


Condition Intervention Phase
Lymphoma
Drug: AZD4877
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 75
Study Start Date: March 2007
Study Completion Date: August 2007
  Eligibility

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

Inclusion Criteria:

  • Patients with AML, a certain type of ALL, NHL and MM
  • certain types of cancer of the lymph nodes
  • certain types of leukemias (blood cancers)
  • disease has or will fail with other treatments
  • 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: NCT00460460

Locations
United States, New York
Research site
Buffalo, New York, United States
Research Site
New York, New York, United States
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Judith Ochs, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00460460     History of Changes
Other Study ID Numbers: D2782C00002
Study First Received: April 12, 2007
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by AstraZeneca:
Phase I
cancer
lymphoma
leukemia
myeloma
AML
ALL
NHL
MM

Additional relevant MeSH terms:
Lymphoma
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014