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

NCT ID: NCT00471367

Last Updated: 2009-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma NHL Non-Hodgkin Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD4877

intravenous infusion administered twice a week for 2 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey Skolnik, MD

Role: STUDY_DIRECTOR

AstraZeneca

Lea Burke

Role: STUDY_CHAIR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

New York, New York, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Greenville, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D2782C00006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.