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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00147485
First received: September 2, 2005
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Neoplasms
Lymphoma, Non-Hodgkin
Drug: AG-024322
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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

Enrollment: 37
Study Start Date: December 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AG-024322

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147485

Locations
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00147485     History of Changes
Other Study ID Numbers: A7091001
Study First Received: September 2, 2005
Last Updated: August 14, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclin-Dependent Kinase Inhibitor Proteins
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014