Kidney NeoplasmsPhase 2NCT00282048
Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
A Phase 2 study testing AG-013736 (axitinib) in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by Pfizer at 5 sites in United States.
Trial summary
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms, Carcinoma, Renal Cell
- What is being tested?
- AG-013736 (axitinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2006to Jun 2009
- Phase
- Phase 2
- 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
- RCC with metastases and nephrectomy
- failure of prior sorafenib-based therapy
- at least 1 target lesion that has not been irradiated
- adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.
Who cannot join
- Gastrointestinal abnormalities
- current use or inability to avoid chronic antacid therapy
- current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
- active seizure disorder or evidence of brain metastases.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111-2497
Pfizer Investigational Site
The Bronx, New York, 10466
About this study
Official title: Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).
- Conditions
- Kidney Neoplasms, Carcinoma, Renal Cell
- Being tested
- AG-013736 (axitinib)
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-013736 (axitinib)Drug
AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles.
| Study group | Role | What they receive |
|---|---|---|
| AG-013736 (axitinib) | Experimental | AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity Receives: Drug: AG-013736 (axitinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
Measured: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Secondary outcomes (5)
Progression-free Survival (PFS)
Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Measured: Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks
Duration of Response (DR)
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Overall Survival (OS)
Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
Measured: Baseline to death due to any cause or at least 1 year after the first dose for the last participant
Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score
FKSI-DRS is a subset of FKSI which is a questionnaire for FACT -Kidney Symptom Index used to assess Quality of Life (QoL)/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.
Measured: Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
Population Pharmacokinetics of Axitinib (AG-013736)
Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Measured: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionFeb 2009
- Study completionJun 2009
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 Kidney 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT00282048
- Sponsor's protocol ID
- A4061023
- Status last verified
- Jul 2012
- First submitted
- 23 Jan 2006
- Last updated
- 31 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00282048
- Acronym / sponsor ID
- A4061023
- Conditions
- Kidney Neoplasms, Carcinoma, Renal Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Posted 3 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AG-013736 (axitinib) | Experimental | Drug: AG-013736 (axitinib)AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- RCC with metastases and nephrectomy
- failure of prior sorafenib-based therapy
- at least 1 target lesion that has not been irradiated
- adequate bone marrow, hepatic and renal function, > or equal to 18 years of age.
Key exclusion criteria (4 listed)
- Gastrointestinal abnormalities
- current use or inability to avoid chronic antacid therapy
- current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
- active seizure disorder or evidence of brain metastases.
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-013736 (axitinib)AG-013736 5 mg twice daily [bid] continuous dosing in 28 day cycles. | Drug | AG-013736 (axitinib) |
Primary outcome
Percentage of Participants With Objective Response (OR)
Time frame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of responses. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 152 weeks
Duration of Response (DR)
Time frame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks
Overall Survival (OS)
Time frame: Baseline to death due to any cause or at least 1 year after the first dose for the last participant
Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index for Disease Cancer Related Symptoms (FKSI-DRS) Score
Time frame: Baseline (Day 1 of Cycle 1), Day 1 of all subsequent cycles up to Cycle 38 and follow up (28 days after last dose)
Population Pharmacokinetics of Axitinib (AG-013736)
Time frame: Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 152 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AG-013736 (axitinib) in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by Pfizer at 5 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 4 inclusion and 4 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2012). 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?
Percentage of Participants With Objective Response (OR) (time frame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 152 weeks). 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 31 Jul 2012.