Renal Cell CarcinomaPhase 2NCT00491738
A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)
A Phase 2 study testing bevacizumab and sunitinib in people with Renal Cell Carcinoma, run by Genentech, Inc..
Trial summary
This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- bevacizumab and sunitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jan 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
- Signed Informed Consent Form
- Histologically confirmed metastatic RCC
- Measurable disease, as defined by RECIST
- Age ≥ 18 years
- ECOG performance status of 0 or 1
- Prior nephrectomy
- Ability and capacity to comply with study and follow-up procedures
Who cannot join
- RCC with predominantly sarcomatoid features
- Prior systemic or adjuvant therapy for RCC
- Radiotherapy for RCC within 28 days prior to Day 1
- Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents
- Current need for dialysis
- Life expectancy of < 12 weeks
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- Current, recent, or planned participation in an experimental drug study
- Inadequate organ function
- Active infection or fever > 38.5°C within 3 days of starting treatment
- History of other malignancies within 5 years prior to Day 1
- Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Class II or greater CHF
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Known CNS disease except for treated brain metastasis
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1
- History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure or anticipation of need for major surgical procedure during the course of the study
- Serious, non-healing wound; active ulcer; or untreated bone fracture
- Known hypersensitivity to any component of bevacizumab
- Pregnancy (positive pregnancy test) or lactation
- Current, ongoing treatment with full-dose warfarin
About this study
Official title: A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer
This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.
- Conditions
- Renal Cell Carcinoma
- Being tested
- bevacizumab, sunitinib, placebo
- Keywords
- RCC, Renal cell cancer, Avastin, Sutent
- 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.
bevacizumabDrug
Intravenous repeating dose
sunitinibDrug
Oral repeating dose
placeboDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab; Drug: sunitinib |
| 2 | Placebo comparator | Not described Receives: Drug: sunitinib; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2008
Why it stopped: Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated.
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 Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Scappaticci, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491738
- Sponsor's protocol ID
- AVF4167g
- Status last verified
- Apr 2009
- First submitted
- 25 Jun 2007
- Last updated
- 10 Apr 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00491738
- Acronym / sponsor ID
- AVF4167g
- Conditions
- Renal Cell Carcinoma
- Keywords
- RCC, Renal cell cancer, Avastin, Sutent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2008 (actual)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Posted 10 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab, Drug: sunitinib |
| 2 | Placebo comparator | Drug: sunitinib, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form
- Histologically confirmed metastatic RCC
- Measurable disease, as defined by RECIST
- Age ≥ 18 years
- ECOG performance status of 0 or 1
Key exclusion criteria (25 listed)
- RCC with predominantly sarcomatoid features
- Prior systemic or adjuvant therapy for RCC
- Radiotherapy for RCC within 28 days prior to Day 1
- Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents
- Current need for dialysis
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 |
|---|---|---|
| bevacizumabIntravenous repeating dose | Drug | 1 |
| sunitinibOral repeating dose | Drug | 1, 2 |
| placeboIntravenous repeating dose | Drug | 2 |
Primary outcome
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Time frame: 5 months
Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2009.
- 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.
Frank Scappaticci, M.D., Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab and sunitinib in people with Renal Cell Carcinoma, run by Genentech, Inc..
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 7 inclusion and 25 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: stopped early, as of the sponsor's last update on 10 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 10 Apr 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?
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) (time frame: 5 months). 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 10 Apr 2009.