A Phase 1 Study Of An Intravenously Administered Cyclin-Dependent Kinase Inhibitor In Patients With Advanced Cancer

August 14, 2008 updated by: Pfizer

A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of AG-024322, An Inhibitor Of Cyclin-Dependent Kinase 1, 2 And 4, Administered Intravenously Daily For 5 Days Every 3 Weeks To Patients With Advanced Cancer

AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors). This research study is the first time that AG-024322 will be given to people.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study was prematurely discontinued due to the inability of the compound to adequately differentiate from other treatment options in the clinical endpoint and necessary product profile on April 13, 2007. Safety profile was not the reason that led to the discontinuation of the program.

Study Type

Interventional

Enrollment (Actual)

37

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced solid tumors or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition
  • Adequate blood cell counts, kidney function and liver function and and ECOG score of 0 or 1.

Exclusion Criteria:

  • Prior high-dose chemotherapy requiring hemapoietic stem cell rescue
  • Previous radiation therapy to >25% of the bone marrow
  • Active or unstable cardiac disease or history of heart attack within 6 months

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AG-024322

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To test the safety of AG-024322 when taken by people who have cancer
To find the AG-024322 dose that should be used in future clinical trials that will study effectiveness
To assess how the human body handles blood concentrations of AG-024322

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

December 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7091001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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