NeoplasmsPhase 1NCT00147485
A Phase 1 Study Of An Intravenously Administered Cyclin-Dependent Kinase Inhibitor In Patients With Advanced Cancer
A Phase 1 study testing AG-024322 in people with Neoplasms and Lymphoma, Non-Hodgkin, run by Pfizer at 4 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Lymphoma, Non-Hodgkin
- What is being tested?
- AG-024322
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2004to Aug 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
About this study
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
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.
- Conditions
- Neoplasms, Lymphoma, Non-Hodgkin
- Being tested
- AG-024322
- Medical subject headings
- Neoplasms, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-024322Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AG-024322 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: See Detailed Description
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147485
- Sponsor's protocol ID
- A7091001
- Status last verified
- Aug 2008
- First submitted
- 2 Sep 2005
- Last updated
- 18 Aug 2008
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00147485
- Acronym / sponsor ID
- A7091001
- Conditions
- Neoplasms, Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AG-024322 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG-024322 | Drug | 1 |
Primary outcome
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
Results and safety
The study was stopped early (reason given: See Detailed Description). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2008.
- Derived from this study: PubMed 19238148Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG-024322 in people with Neoplasms and Lymphoma, Non-Hodgkin, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: See Detailed Description). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the safety of AG-024322 when taken by people who have cancer. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00147485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.