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

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT00471367

Collaborator

(none)

Enrollment

Locations

Duration (Months)

14.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma NHL Non-Hodgkin Lymphoma	Drug: AZD4877	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2007

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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