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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00471367
• Other study ID #: D2782C00006
• Status: Terminated
• Phase: Phase 1
• First received: May 7, 2007
• Last updated: September 23, 2009
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• NHL
• Non-Hodgkin Lymphoma

Intervention

Drug:
• AZD4877
intravenous infusion administered twice a week for 2 weeks

Locations

Country	Name	City	State
United States	Research Site	Greenville	South Carolina
United States	Research Site	New York	New York
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities		on a twice a week schedule for two weeks out of every three weeks	No
Secondary	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		assessed after each course of treatment	No
Secondary	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		Assessed during treatment and post treatment	No

External Links

•   US and Canada only