Carcinoma, Renal CellPhase 2NCT00254540
Study of SU011248 in Patients With Advanced Kidney Cancer
A Phase 2 study testing SU011248 capsule in people with Carcinoma, Renal Cell, run by Pfizer at 11 sites in Japan.
Trial summary
To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- SU011248 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 11 sitesJapan
- Study dates
- Dec 2005to Feb 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven renal cell carcinoma with metastases with a component of clear cell histology
Who cannot join
- Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Pfizer Investigational Site
Akita, Akita
Pfizer Investigational Site
Chuo-ku, Tokyo
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Hamamatsu, Shizuoka
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Sayama, Osaka
Pfizer Investigational Site
Sunto-gun, Shizuoka
Pfizer Investigational Site
Tokushima, Tokushima
Pfizer Investigational Site
Tsukuba, Ibaragi
Pfizer Investigational Site
Yamagata, Yamagata
About this study
Official title: Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).
- Conditions
- Carcinoma, Renal Cell
- Being tested
- SU011248 capsule
- Keywords
- Ph2, RCC, SU011248, SUNITINIB
- Medical subject headings
- Carcinoma, Renal Cell, Primary hyperoxaluria type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248 capsuleDrug
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| SU-011248 capsule | Experimental | Not described Receives: Drug: SU011248 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Objective Response
Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Day 28 of Cycles 1-4
Secondary outcomes (15)
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.
Measured: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
Time To Tumor Progression (TTP)
Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).
Measured: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
Duration of Response (DR)
Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.
Measured: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
Time to Tumor Response (TTR)
Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.
Overall Survival Time
Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.
Measured: once year. Up to 3 years after the completion of subject registration.
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.
Measured: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline.
The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Measured: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.
Measured: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Measured: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Measured: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.
The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject.
Measured: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.
The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject.
Measured: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)
Measured: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Measured: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2009
- Study completionFeb 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 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
- 51 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
- NCT00254540
- Sponsor's protocol ID
- A6181072
- Status last verified
- Feb 2010
- First submitted
- 14 Nov 2005
- Last updated
- 23 Feb 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 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00254540
- Acronym / sponsor ID
- A6181072
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Ph2, RCC, SU011248, SUNITINIB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Nov 2005 (estimated)
- Results
- Posted 11 Feb 2010
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 objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SU-011248 capsule | Experimental | Drug: SU011248 capsule |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically proven renal cell carcinoma with metastases with a component of clear cell histology
Key exclusion criteria (1 listed)
- Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.
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 |
|---|---|---|
| SU011248 capsule50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops | Drug | SU-011248 capsule |
Primary outcome
Number of Subjects With Objective Response
Time frame: Day 28 of Cycles 1-4
Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
15 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
Time To Tumor Progression (TTP)
Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
Duration of Response (DR)
Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.
Time to Tumor Response (TTR)
Time frame: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.
Overall Survival Time
Time frame: once year. Up to 3 years after the completion of subject registration.
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Time frame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Time frame: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Time frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population
Time frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
Time frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population
Time frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
Time frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population
Time frame: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Time frame: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Time frame: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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 SU011248 capsule in people with Carcinoma, Renal Cell, run by Pfizer at 11 sites in Japan.
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 1 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 23 Feb 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 Japan. 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 11 Feb 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 Objective Response (time frame: Day 28 of Cycles 1-4). 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 23 Feb 2010.