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

Phase 1

Terminated

• Conditions: Lymphoma; NHL; Non-Hodgkin Lymphoma

• Registration Number: NCT00471367
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-07
• Study First Submitted QC: 2007-05-07
• Study First Posted: 2007-05-09
• Study Completion: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

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Exclusion Criteria

• Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Greenville, South Carolina, United States