Non-Small Cell Lung CancerPhase 2NCT00434226
A Study of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer (SABRE-L)
A Phase 2 study testing bevacizumab, sunitinib and carboplatin in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..
Trial summary
This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- bevacizumab, sunitinib and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Apr 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
- Age ≥ 18 years
- Advanced histologically or cytologically confirmed NSCLC (Stage IIIb with malignant pleural or pericardial effusion, Stage IV, or recurrent)
- Measurable or non-measurable disease
- Patients with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period (brain imaging to be competed Day -7 to Day 1).
- Prior treatment for CNS disease as deemed appropriate by the treating physician
- ECOG performance status 0 or 1
- Ability and willingness to comply with study and follow-up procedures
Who cannot join
- Prior systemic chemotherapy for metastatic disease
- Active malignancy other than lung cancer
- Current, recent, or planned participation in another experimental drug study
- Prior treatment with anti-VEGF agent or agents targeting similar pathways as sunitinib
- Adjuvant chemotherapy or prior combined modality neoadjuvant therapy (chemotherapy plus radiotherapy with or without surgery) within 6 months prior to Day 1 of Cycle 1
- Life expectancy of < 12 weeks
Show all 30Show fewer
- Current, recent, or planned participation in an experimental drug study
- Inability to take oral medication or requirement of IV alimentation or total parenteral nutrition, or prior surgical procedures affecting absorption
- Inadequate organ function
- Known evidence of disseminated intravascular coagulopathy
- Active infection or fever > 38.5°C within 3 days prior to Day 1 of Cycle 1
- Untreated abnormal thyroid function tests as defined by institutional standards (patients with controlled hypothyroidism are eligible for study participation)
- Any other medical condition(s) (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
- Intrathoracic lung carcinoma of squamous cell histology
- Known CNS disease except for treated brain metastases
- 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 12 months prior to Day 1 of Cycle 1
- History of stroke or transient ischemic attack within 12 months prior to Day 1 of Cycle 1
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1 of Cycle 1
- History of hemoptysis within 1 month prior to Day 1 of Cycle 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 of Cycle 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 of Cycle 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria at screening, as demonstrated by a urine protein/creatinine ratio of ≥ 1.0 at screening
- Known hypersensitivity to any component of bevacizumab or sunitinib
- Pregnancy (positive pregnancy test) or lactation
About this study
Official title: A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
This is a Phase II, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- bevacizumab, sunitinib, carboplatin, paclitaxel
- Keywords
- SABER-L, NSCLC, Avastin, Sutent
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Intravenously at a dose of 15mg/kg on the first day of each 21-day cycle
sunitinibDrug
25 mg/day for 2 weeks, followed by 1 week of rest
carboplatinDrug
On the first day of each cycle for 4 cycles
paclitaxelDrug
On the first day of each cycle for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Experimental | Not described Receives: Drug: bevacizumab; Drug: sunitinib; Drug: carboplatin; Drug: paclitaxel |
| Bevacizumab + Carboplatin/Paclitaxel | Placebo comparator | Not described Receives: Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Response
The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
Measured: From randomization until disease progression/recurrence
Secondary outcomes (4)
Serious Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 60 days following the last administration of study treatment
Incidence of Grade ≥ 3 Adverse Events
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
Measured: 60 days following the last administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
Why it stopped: Based on data collected, the combination appeared to be poorly tolearated.
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 Non-Small Cell Lung CancerStudies 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
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Julie Hambleton, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434226
- Sponsor's protocol ID
- AVF3996g
- Status last verified
- Jul 2009
- First submitted
- 11 Feb 2007
- Last updated
- 21 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multicenter, Phase II Study of the Safety and Efficacy of Sunitinib in Combination With Bevacizumab, Carboplatin, and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00434226
- Acronym / sponsor ID
- AVF3996g
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- SABER-L, NSCLC, Avastin, Sutent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on data collected, the combination appeared to be poorly tolearated.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 13 Feb 2007 (estimated)
- Results
- Posted 21 Aug 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, randomized, controlled, open-label, multicenter trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with carboplatin and paclitaxel chemotherapy and bevacizumab in patients with locally advanced, recurrent or metastatic NSCLC who have not received prior systemic therapy for NSCLC. All patients will have advanced, histologically or cytologically confirmed NSCLC (Stage IIIb with pleural effusions, Stage IV, or recurrent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + Carboplatin/Paclitaxel + Sunitinib | Experimental | Drug: bevacizumab, Drug: sunitinib, Drug: carboplatin, Drug: paclitaxel |
| Bevacizumab + Carboplatin/Paclitaxel | Placebo comparator | Drug: bevacizumab, Drug: carboplatin, Drug: paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- Age ≥ 18 years
- Advanced histologically or cytologically confirmed NSCLC (Stage IIIb with malignant pleural or pericardial effusion, Stage IV, or recurrent)
- Measurable or non-measurable disease
- Patients with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period (brain imaging to be competed Day -7 to Day 1).
Key exclusion criteria (30 listed)
- Prior systemic chemotherapy for metastatic disease
- Active malignancy other than lung cancer
- Current, recent, or planned participation in another experimental drug study
- Prior treatment with anti-VEGF agent or agents targeting similar pathways as sunitinib
- Adjuvant chemotherapy or prior combined modality neoadjuvant therapy (chemotherapy plus radiotherapy with or without surgery) within 6 months prior to Day 1 of Cycle 1
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 |
|---|---|---|
| bevacizumabIntravenously at a dose of 15mg/kg on the first day of each 21-day cycle | Drug | Bevacizumab + Carboplatin/Paclitaxel, Bevacizumab + Carboplatin/Paclitaxel + Sunitinib |
| sunitinib25 mg/day for 2 weeks, followed by 1 week of rest | Drug | Bevacizumab + Carboplatin/Paclitaxel + Sunitinib |
| carboplatinOn the first day of each cycle for 4 cycles | Drug | Bevacizumab + Carboplatin/Paclitaxel, Bevacizumab + Carboplatin/Paclitaxel + Sunitinib |
| paclitaxelOn the first day of each cycle for 4 cycles | Drug | Bevacizumab + Carboplatin/Paclitaxel, Bevacizumab + Carboplatin/Paclitaxel + Sunitinib |
Primary outcome
Best Response
Time frame: From randomization until disease progression/recurrence
The best overall response is the best response, per RECIST criteria, recorded from randomization until disease progression/recurrence (includes both confirmed and unconfirmed responses). Although the original primary outcome was progression-free survival, there was insufficient data available to report on that outcome.
4 secondary outcomes
Serious Adverse Events
Time frame: 60 days following the last administration of study treatment
Incidence of Grade ≥ 3 Adverse Events
Time frame: 60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Sunitinib Discontinuation, Dose Interruption, or Dose Reduction
Time frame: 60 days following the last administration of study treatment
Incidence of Adverse Events Leading to Bevacizumab Discontinuation or Dose Interruption
Time frame: 60 days following the last administration of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
Julie Hambleton, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, sunitinib and carboplatin in people with Non-Small Cell Lung Cancer, 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 8 inclusion and 30 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 21 Aug 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 21 Aug 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?
Best Response (time frame: From randomization until disease progression/recurrence). 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 21 Aug 2009.