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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00147485
• Collaborator: (none)
• Enrollment: 37
• Locations: 4
• Arm: 1
• Duration (Months): 32
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neoplasms; Lymphoma, Non-Hodgkin	Drug: AG-024322	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To test the safety of AG-024322 when taken by people who have cancer []

2. To find the AG-024322 dose that should be used in future clinical trials that will study effectiveness []

3. To assess how the human body handles blood concentrations of AG-024322 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Boston	Massachusetts	United States	02114
2	Pfizer Investigational Site	Boston	Massachusetts	United States	02115
3	Pfizer Investigational Site	Boston	Massachusetts	United States	02215
4	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00147485
• Other Study ID Numbers: A7091001
• First Posted: Sep 7, 2005
• Last Update Posted: Aug 18, 2008
• Last Verified: Aug 1, 2008

• Additional relevant MeSH terms: Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Aug 18, 2008