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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00460460
• Other study ID #: D2782C00002
• Status: Terminated
• Phase: Phase 1
• First received: April 12, 2007
• Last updated: January 24, 2011
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• AZD4877

Locations

Country	Name	City	State
Canada	Research Site	Toronto	Ontario
United States	Research site	Buffalo	New York
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,