Carcinoma, Renal CellPhase 4MRCC RCCNCT00706706
Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma
A Phase 4 study testing Sunitinib Malate (SU011248) in people with Carcinoma, Renal Cell, run by Pfizer at 11 sites in China.
Trial summary
To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma. 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 Malate (SU011248)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 11 sitesChina
- Study dates
- Jul 2008to Aug 2011
- Phase
- Phase 4
- 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 with a component of clear (conventional) cell histology that is not amenable to surgery.
- Evidence of unidimensionally measurable disease
- Male or female, 18 years of age or older.
- ECOG performance status 0 or 1.
- Resolution of all acute toxic effects
- Adequate organ function.
Who cannot join
- Renal cell carcinoma without any clear (conventional) cell component.
- Prior systemic therapy for metastatic disease of any kind of RCC, such as Interferon or Interleukin, chemotherapy, hormonal, investigational or targeted therapies. Patients may have received prior adjuvant therapy with Interferon and/or Interleukin if recurrence occurred > 6 months after adjuvant therapy completion.
- Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
- NCI CTCAE grade 3 hemorrhage <4 weeks of starting the study treatment.
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI scan.
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- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, and 6 months for pulmonary embolism.
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- Ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
- Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
- Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Current treatment on another clinical trial.
- Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Pfizer Investigational Site
Beijing, 100021
Pfizer Investigational Site
Beijing, 100034
Pfizer Investigational Site
Beijing, 100036
Pfizer Investigational Site
Chongqing, 400038
Pfizer Investigational Site
Guangzhou, Guangdong, 510060
Pfizer Investigational Site
Nanjing, Jiangsu, 210002
Pfizer Investigational Site
Shanghai, 200032
Pfizer Investigational Site
Shanghai, 200127
Pfizer Investigational Site
Tianjin, 300060
Pfizer Investigational Site
Wuhan, Hubei, 430030
Pfizer Investigational Site
Xi'an, 710032
About this study
Official title: A Single-Arm, Open-Label, Multi-Center, Phase Iv, Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (Post Approval Commitment Study)
To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Sunitinib Malate (SU011248)
- Keywords
- sunitinib Phase IV metastatic renal cell carcinoma Chinese
- 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.
Sunitinib Malate (SU011248)Drug
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
| Study group | Role | What they receive |
|---|---|---|
| sunitinib | Experimental | single agent sunitinib, single arm Receives: Drug: Sunitinib Malate (SU011248) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Time in weeks 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) divided by 7. 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, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Secondary outcomes (3)
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 response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Measured: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Overall Survival (OS)
Time in weeks 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) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Measured: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
One Year Survival Probability
One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.
Measured: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2011
- Study completionAug 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 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
- NCT00706706
- Sponsor's protocol ID
- A6181132
- Acronym
- MRCC RCC
- Status last verified
- Jan 2013
- First submitted
- 25 Jun 2008
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multi-Center, Phase Iv, Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (Post Approval Commitment Study)
- ClinicalTrials.gov ID
- NCT00706706
- Acronym / sponsor ID
- MRCC RCC / A6181132
- Conditions
- Carcinoma, Renal Cell
- Keywords
- sunitinib Phase IV metastatic renal cell carcinoma Chinese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 20 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib | Experimental | Drug: Sunitinib Malate (SU011248)single agent sunitinib, single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology that is not amenable to surgery.
- Evidence of unidimensionally measurable disease
- Male or female, 18 years of age or older.
- ECOG performance status 0 or 1.
- Resolution of all acute toxic effects
Key exclusion criteria (15 listed)
- Renal cell carcinoma without any clear (conventional) cell component.
- Prior systemic therapy for metastatic disease of any kind of RCC, such as Interferon or Interleukin, chemotherapy, hormonal, investigational or targeted therapies. Patients may have received prior adjuvant therapy with Interferon and/or Interleukin if recurrence occurred > 6 months after adjuvant therapy completion.
- Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
- NCI CTCAE grade 3 hemorrhage <4 weeks of starting the study treatment.
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
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 |
|---|---|---|
| Sunitinib Malate (SU011248)Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg. | Drug | sunitinib |
Primary outcome
Progression-free Survival (PFS)
Time frame: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Time in weeks 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) divided by 7. 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").
3 secondary outcomes
Percentage of Participants With Objective Response (OR)
Time frame: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
Overall Survival (OS)
Time frame: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)
One Year Survival Probability
Time frame: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- 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 4 study testing Sunitinib Malate (SU011248) in people with Carcinoma, Renal Cell, run by Pfizer at 11 sites in China.
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 6 inclusion and 15 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 18 Jan 2013. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Dec 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?
Progression-free Survival (PFS) (time frame: Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 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 18 Jan 2013.