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TerminatedNCT00147485Updated Aug 18, 2008

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

A Phase 1 interventional study of AG-024322 in Neoplasms and Lymphoma, Non-Hodgkin, sponsored by Pfizer. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-18.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Why this study was terminated
See Detailed Description
Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Neoplasms
  • Lymphoma, Non-Hodgkin
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 37 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    1

    Drug: AG-024322

Interventions

  • DrugAG-024322
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What researchers measure

Primary outcomes

  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

07

Study locations

4 sites
  • Pfizer Investigational Site
    Boston, Massachusetts 02114, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02115, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02215, United States
  • Pfizer Investigational Site
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Publications

  • Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602. PubMed 19238148 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00147485
Lead sponsor
Pfizer
First posted
Sep 7, 2005
Start date
Dec 2004
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Aug 18, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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