Carcinoma, Renal CellPhase 2NCT00089648
SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma
A Phase 2 study testing Sunitinib in people with Carcinoma, Renal Cell, run by Pfizer at 11 sites in United States.
Trial summary
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment. 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?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2004to Mar 2008
- 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
- Histologically proven renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease
- Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
- Prior radical or partial nephrectomy
Who cannot join
- Prior treatment with any other anti-angiogenic therapy other than bevacizumab
- Prior systemic treatment for RCC > 2 regimens
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Chicago, Illinois, 60637-1460
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Duarte, California, 91010
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Nashville, Tennessee, 37232-5536
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
San Francisco, California, 94115
About this study
Official title: A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- 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.
SunitinibDrug
Also called SUTENT, SU011248,
50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 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: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Secondary outcomes (12)
Time to Tumor Progression (TTP)
TTP was defined as the time from the date of first dose of study medication to the date of the first documentation of 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: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Duration of Response (DR)
DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was only calculated for the subgroup of subjects with a confirmed objective response. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. Kaplan-Meier method was used.
Measured: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Overall Survival (OS)
OS was defined as the time from start of study treatment to date of death due to any cause. OS (in weeks) was calculated as [date of death minus first dose date +1]/7. For a subject not expiring, the OS time was censored on the last date of known contact that they were known to be alive. Subjects lacking data beyond the day of the first dose had their OS times censored at 1 day. Kaplan-Meier method was used.
Measured: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Progression Free Survival (PFS)
PFS was defined as the time from start of study medication to first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, 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: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Trough Plasma Concentrations (Cmin) of Sunitinib
Measured: Day 28 of Cycle 1 to Cycle 4
Trough Plasma Concentrations (Cmin) of SU012662
Measured: Day 28 of Cycle 1 to Cycle 4
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
Measured: Day 28 of Cycle 1 to Cycle 4
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
Plasma concentrations of VEGF-A that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Measured: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Measured: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)
Plasma Concentration of Placental Growth Factor (PlGF)
Plasma concentrations of PlGF that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Measured: Cycle 1 (Days 1, 14, and 28)
Plasma Concentration of VEGF-C
Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.
Measured: Cycle 1 (Days 1, 14, and 28)
Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)
Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were to have been analyzed by ELISA analysis; however, no data were collected.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2004 (estimated)
- Study startDec 2004
- Primary completionJan 2007
- Study completionMar 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT00089648
- Sponsor's protocol ID
- A6181039
- Status last verified
- Jan 2010
- First submitted
- 9 Aug 2004
- Last updated
- 12 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00089648
- Acronym / sponsor ID
- A6181039
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 11 Aug 2004 (estimated)
- Results
- Posted 21 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.
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: Sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease
- Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
- Prior radical or partial nephrectomy
Key exclusion criteria (4 listed)
- Prior treatment with any other anti-angiogenic therapy other than bevacizumab
- Prior systemic treatment for RCC > 2 regimens
- History of or known brain metastases
- Serious acute or chronic illness or recent history of significant cardiac abnormality
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 |
|---|---|---|
| SunitinibAlso: SUTENT, SU011248,50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol | Drug | 1 |
Primary outcome
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
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.
12 secondary outcomes
Time to Tumor Progression (TTP)
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Duration of Response (DR)
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Overall Survival (OS)
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Progression Free Survival (PFS)
Time frame: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Trough Plasma Concentrations (Cmin) of Sunitinib
Time frame: Day 28 of Cycle 1 to Cycle 4
Trough Plasma Concentrations (Cmin) of SU012662
Time frame: Day 28 of Cycle 1 to Cycle 4
Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)
Time frame: Day 28 of Cycle 1 to Cycle 4
Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)
Time frame: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)
Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)
Time frame: Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)
Plasma Concentration of Placental Growth Factor (PlGF)
Time frame: Cycle 1 (Days 1, 14, and 28)
Plasma Concentration of VEGF-C
Time frame: Cycle 1 (Days 1, 14, and 28)
Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- 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.
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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
11 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 Sunitinib in people with Carcinoma, Renal Cell, run by Pfizer at 11 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 21 Dec 2009). 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: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up). 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 12 Jan 2010.