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

September 23, 2009 updated by: AstraZeneca

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: AZD4877

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States
    - Research Site
- South Carolina
  - Greenville, South Carolina, United States
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities Time Frame: on a twice a week schedule for two weeks out of every three weeks	on a twice a week schedule for two weeks out of every three weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: assessed after each course of treatment	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 Time Frame: Assessed during treatment and post treatment	Assessed during treatment and post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Jeffrey Skolnik, MD, AstraZeneca
Study Chair: Lea Burke, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 7, 2007

First Submitted That Met QC Criteria