Solid TumorsNCT00828919
Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials
A study testing axitinib and crizotinib in people with Solid Tumors, run by Pfizer at 34 sites in 11 countries.
Trial summary
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- axitinib and crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 34 sitesin 11 countries
- Study dates
- 7 Mar 2003to 14 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
- Patients who were receiving axitinib (AG-013736) tablets at the time their previous trial ended
- Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous axitinib (AG-013736) protocol should be used to determine stable or responding disease).
- Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol
Who cannot join
- Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met
Trial locations and contacts
34 sites in 11 countries.
34 sites in 11 countries
United States18 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21205
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
University of Chicago Hospitals
Chicago, Illinois, 60637
The Cleveland Clinic
Cleveland, Ohio, 44195
Providence Regional Medical Center Everett - Providence Regional Cancer Partnership
Everett, Washington, 98201
Providence Regional Medical Center Everett
Everett, Washington, 98201
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin - Hospital and Clinics
Madison, Wisconsin, 53792
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
UC Irvine Medical Center
Orange, California, 92868
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
UCLA Hematology-Oncology-Santa Monica
Santa Monica, California, 90404
Japan5 sites
Chiba Cancer Center
Chiba, 260-8717
Kyushu University Hospital
Fukuoka, 812-8582
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Nagasaki University Hospital
Nagasaki, 852-8501
Kinki University Hospital
Sayama, Osaka, 589-8511
Czechia2 sites
Fakultni nemocnice Olomouc
Olomouc, Czech Republic, 77900
Nemocnice Na Bulovce
Prague, 18081
Italy2 sites
Fondazione IRCCS, Istituto Nazionale Tumori, Laboratorio
Milan, 20133
Fondazione IRCCS, Istituto Nazionale Tumori, S.S.D Oncologia Medica dei Tumori testa-collo
Milan, 20133
Germany1 site
Charité - Universitaetsmedizin Berlin, Charité Campus Mitte
Berlin, 10117
Russia1 site
FSBSI "N.N. Blokhin Russian Cancer Research Center"
Moscow, Russian Federation, 115478
United Kingdom1 site
Nottingham City Hospital / Oncology Department
Nottingham, NG5 1PB
About this study
Official title: CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
Read the detailed description
This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure.
- Conditions
- Solid Tumors
- Being tested
- axitinib, crizotinib
- Keywords
- VEGFR inhibitor, angi-angiogenic, tyrosine kinase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axitinibDrug
Also called AG-013736
BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial
crizotinibDrug
Also called PF-02341066
BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study Receives: Drug: axitinib; Drug: crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of an AE to study drug was based on investigator's assessment. AEs included both serious and non-serious AEs.
Measured: Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study start7 Mar 2003
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Model description
- This is a continuing access, open label study for patients to receive monotherapy or combination therapy based on previous treatment received in parent protocol
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828919
- Sponsor's protocol ID
- A4061008
- Other IDs
- 2005-000051-15, 2005
- Status last verified
- Nov 2024
- First submitted
- 23 Jan 2009
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2, AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN CLINICAL TRIALS
- ClinicalTrials.gov ID
- NCT00828919
- Acronym / sponsor ID
- A4061008
- Conditions
- Solid Tumors
- Keywords
- VEGFR inhibitor, angi-angiogenic, tyrosine kinase inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2003 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial
Detailed description
This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a continuing access, open label study for patients to receive monotherapy or combination therapy based on previous treatment received in parent protocol
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: axitinib, Drug: crizotinibPatients continue the same treatment (axitinib monotherapy or in combination with crizotinib) as in prior axitinib study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
- Patients who were receiving axitinib (AG-013736) tablets at the time their previous trial ended
- Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous axitinib (AG-013736) protocol should be used to determine stable or responding disease).
- Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol
Key exclusion criteria (1 listed)
- Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met
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 |
|---|---|---|
| axitinibAlso: AG-013736BID oral tablets. dose of axitinib (AG 013736) will be the same as they were taking in the previous trial | Drug | Treatment |
| crizotinibAlso: PF-02341066BID oral Capsules. Dose of crizotinib will be the same taken in previous axitinib trial. | Drug | Treatment |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs
Time frame: Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of an AE to study drug was based on investigator's assessment. AEs included both serious and non-serious AEs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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
34 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axitinib and crizotinib in people with Solid Tumors, run by Pfizer at 34 sites in 11 countries.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Japan, Czechia, Italy, France and 6 more countries. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs and Treatment Related Serious TEAEs (time frame: Day 1 up to 28 days after last dose of study drug (maximum treatment exposure was 119.56 months; maximum follow-up to approximately 120.56 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2024.