Carcinoma, Renal CellPhase 1/2NCT00113529
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
A Phase 1/2 study testing Gefitinib + Sunitinib in people with Carcinoma, Renal Cell, run by Pfizer at 3 sites in United States.
Trial summary
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Gefitinib + Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2004to Oct 2008
- Phase
- Phase 1/2
- 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
- Histologically confirmed renal cell carcinoma with metastases
- Evidence of unidimensionally measurable disease
- Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC
Who cannot join
- RCC without any clear (conventional) cell component
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Gefitinib + Sunitinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib + SunitinibDrug
Also called Iressa, SU011248, SUTENT
Until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib + Gefitinib | Experimental | Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib
Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib Receives: Drug: Gefitinib + Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Secondary outcomes (29)
Time to Tumor Response (TTR)
TTR was defined as the time from date of the first dose of study medication to first documentation of objective tumor response (CR or PR). For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. If lesion assessment data included more than 1 date, the first date was used. TTR was calculated as (first event date minus first dose date +1)/7. TTR was calculated based on the subgroup of subjects with a baseline disease assessment, who had the correct histological cancer type, and had a confirmed objective tumor response. Kaplan-Meier method was used.
Measured: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Duration of Response (DR)
DR was defined as the time from start of the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1)/7. DR was calculated for the subgroup of subjects with an objective tumor response (CR or PR).
Measured: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
Time to Tumor Progression (TTP)
TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Measured: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Overall Survival (OS)
OS was defined as the time from date of the first dose of study medication to date of death due to any cause. OS (in weeks) is calculated as (date of death minus first dose date +1)/7. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose had their survival times censored at 1 day. Kaplan-Meier method was used.
Measured: From start of study treatment until death
Progression-Free Survival (PFS)
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Measured: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
Probability of Survival at One Year
Survival rate was defined as the percentage of subjects alive at 1 year after the date of first administration of study medication. Survival rate was estimated using the Kaplan-Meier method.
Measured: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
Concentration of VEGF at baseline.
Measured: Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
VEGF concentration at each time point divided by VEGF concentration at baseline (ratio to baseline).
Measured: Baseline to Cycle 3, Day 28 inclusive
VEGF-C Concentration at Baseline
Concentration of VEGF-C at baseline.
Measured: Baseline (Cycle 1, Day 1)
VEGF-C Ratio to Baseline at Each Time Point
VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
Measured: Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Concentration of sVEGFR2 at baseline.
Measured: Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
sVEGFR2 concentration at each time point divided by sVEGFR2 concentration at baseline (ratio to baseline).
Measured: Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
Concentration of sVEGFR3 at baseline.
Measured: Baseline (Cycle 1, Day 1)
sVEGFR3 Ratio to Baseline at Each Time Point
sVEGFR3 concentration at each time point divided by sVEGFR3 concentration at baseline (ratio to baseline).
Measured: Baseline to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Change = median VEGF level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Change = median VEGFC level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Change = median VEGFR2 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Change = median VEGFR3 level at each specified time point for subjects with tumor response (CR or PR or [SD > = 6 weeks] versus PD) minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
Change = median VEGF level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
Change = median VEGFC level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
Change = median VEGFR2 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
Change = median VEGFR3 level at each specified time point for subjects with tumor response PFS >= Median or PFS < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
Change = median VEGF level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGF level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
Change = median VEGFC level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFC level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
Change = median VEGFR2 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR2 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
Change = median VEGFR3 level at each specified time point for subjects with tumor response TTP >= Median and TTP < Median minus median VEGFR3 level at Baseline. A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
Measured: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Trough Plasma Concentrations (Ctrough) of Sunitinib
Measured: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of SU-012662 (Sunitinib's Metabolite)
Measured: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of Gefitinib
Measured: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2007
- Study completionOct 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT00113529
- Sponsor's protocol ID
- A6181038
- Status last verified
- Aug 2011
- First submitted
- 8 Jun 2005
- Last updated
- 29 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Motzer RJ, Hudes GR, Ginsberg MS, Baum MS, Harmon CS, Kim ST, Chen I, Redman BG. Phase I/II trial of sunitinib plus gefitinib in patients with metastatic renal cell carcinoma. Am J Clin Oncol. 2010 Dec;33(6):614-8. doi: 10.1097/COC.0b013e3181c4454d.
PubMed 20142724
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Gefitinib (Iressa) In Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00113529
- Acronym / sponsor ID
- A6181038
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Jun 2005 (estimated)
- Results
- Posted 31 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib + Gefitinib | Experimental | Drug: Gefitinib + SunitinibPhase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed renal cell carcinoma with metastases
- Evidence of unidimensionally measurable disease
- Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC
Key exclusion criteria (3 listed)
- RCC without any clear (conventional) cell component
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry
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 |
|---|---|---|
| Gefitinib + SunitinibAlso: Iressa, SU011248, SUTENTUntil disease progression or unacceptable toxicity. | Drug | Sunitinib + Gefitinib |
Primary outcome
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
29 secondary outcomes
Time to Tumor Response (TTR)
Time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Duration of Response (DR)
Time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death due to cancer
Time to Tumor Progression (TTP)
Time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter
Overall Survival (OS)
Time frame: From start of study treatment until death
Progression-Free Survival (PFS)
Time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter or death
Probability of Survival at One Year
Time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter up until 1 year
VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline
Time frame: Baseline (Cycle 1, Day 1)
VEGF Ratio to Baseline at Each Time Point
Time frame: Baseline to Cycle 3, Day 28 inclusive
VEGF-C Concentration at Baseline
Time frame: Baseline (Cycle 1, Day 1)
VEGF-C Ratio to Baseline at Each Time Point
Time frame: Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline
Time frame: Baseline (Cycle 1, Day 1)
sVEGFR2 Ratio to Baseline at Each Time Point
Time frame: Baseline to Cycle 3, Day 28 inclusive
Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline
Time frame: Baseline (Cycle 1, Day 1)
sVEGFR3 Ratio to Baseline at Each Time Point
Time frame: Baseline to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD)
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median
Time frame: Baseline (Cycle 1, Day 1) to Cycle 3, Day 28 inclusive
Trough Plasma Concentrations (Ctrough) of Sunitinib
Time frame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of SU-012662 (Sunitinib's Metabolite)
Time frame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Ctrough of Gefitinib
Time frame: prior to dosing on Cycle 1 (Days 1, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20142724Motzer RJ, Hudes GR, Ginsberg MS, Baum MS, Harmon CS, Kim ST, Chen I, Redman BG. Phase I/II trial of sunitinib plus gefitinib in patients with metastatic renal cell carcinoma. Am J Clin Oncol. 2010 Dec;33(6):614-8. doi: 10.1097/COC.0b013e3181c4454d.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gefitinib + Sunitinib in people with Carcinoma, Renal Cell, run by Pfizer at 3 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 3 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: finished, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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 31 Mar 2010). 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 Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: From start of treatment until Day 28 of Cycles 1 to 4, Day 28 of even cycles thereafter). 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 NCT00113529, 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 29 Aug 2011.