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

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ClinicalTrials.gov Identifier: NCT00460460
Recruitment Status : Terminated (Study was terminated due to low enrollment)
First Posted : April 16, 2007
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma Drug: AZD4877 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Actual Study Completion Date : August 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00460460     History of Changes
Other Study ID Numbers: D2782C00002
First Posted: April 16, 2007    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: January 2011

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