Carcinoma, Non-Small-Cell LungPhase 1NCT01069328
Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Nexavar (Sorafenib, BAY43-9006), Bevacizumab and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung and Lung Cancer, run by Bayer at 2 sites in United States.
Trial summary
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Lung Cancer
- What is being tested?
- Nexavar (Sorafenib, BAY43-9006), Bevacizumab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
- Age >/= 18 years old
- Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
- ECOG Performance Status of 0 to 1
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
- Hemoglobin >/= 9.0 g/dL
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- White blood cell (WBC) count >/= 2,500/mm3
- Absolute neutrophil count (ANC) >/= 1,500/mm3
- Platelet count >/= 100,000/mm3
- Total bilirubin </= 1.5 times the upper limit of normal (ULN)
- ALT and AST </= 2.5 X ULN (</= 5 X ULN for patients with liver involvement)
- INR </= 1.5 and aPTT within normal limits
- Serum creatinine </= ULN or creatinine clearance (CrCl) >/= 45 mL/min (CrCl = Wt (kg) x (140-age)/72 x Cr level, female x 0.85) for patients with creatinine levels above institutional normal
- Urinalysis (UA) must show less than 1+ protein in urine, or the patient will require a repeat UA. If repeat UA shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
Who cannot join
- Patients with squamous histology
- Cardiac disease: Congestive heart failure > Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
- HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> Grade 2 NCI-CTC Version 3.0)
- Evidence or history of CNS disease, including primary brain tumors, seizures disorders, or any brain metastasis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Houston, Texas, 77030
Study site
Rochester, Minnesota, 55905
About this study
Official title: Study of BAY43-9006 (Sorafenib) in Combination With Carboplatin, Paclitaxel and Bevacizumab in Previously Untreated Patients With Stage IIIB (With Malignant Pleural Effusions) or Stage IV Non-small Cell Lung Cancer (NSCLC)
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Cancer
- Being tested
- Nexavar (Sorafenib, BAY43-9006), Bevacizumab, Paclitaxel, Carboplatin
- Keywords
- Lung, cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexavar (Sorafenib, BAY43-9006)Drug
Sorafenib 200 mg orally BID interrupted dosing
Nexavar (Sorafenib, BAY43-9006)Drug
Sorafenib 400 mg orally BID interrupted dosing
BevacizumabDrug
Bevacizumab 2.5 mg/kg intravenously
BevacizumabDrug
Bevacizumab 5 mg/kg intravenously
BevacizumabDrug
Bevacizumab 7.5 mg/kg intravenously
BevacizumabDrug
Bevacizumab 10 mg/kg intravenously
PaclitaxelDrug
Paclitaxel 200 mg/m² intravenously
CarboplatinDrug
Carboplatin AUC 6 intravenously
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
| Arm 2 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
| Arm 3 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
| Arm 4 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
| Arm 5 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
| Arm 6 | Experimental | Not described Receives: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab
Measured: 2 years
Secondary outcomes (1)
The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJul 2006
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by BayerThe 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069328
- Sponsor's protocol ID
- 11956
- Status last verified
- Nov 2013
- First submitted
- 15 Feb 2010
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of BAY43-9006 (Sorafenib) in Combination With Carboplatin, Paclitaxel and Bevacizumab in Previously Untreated Patients With Stage IIIB (With Malignant Pleural Effusions) or Stage IV Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01069328
- Acronym / sponsor ID
- 11956
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Cancer
- Keywords
- Lung, cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
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 tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006), Drug: Bevacizumab, Drug: Paclitaxel, Drug: Carboplatin |
| Arm 2 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006), Drug: Bevacizumab, Drug: Paclitaxel, Drug: Carboplatin |
| Arm 3 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006), Drug: Bevacizumab, Drug: Paclitaxel, Drug: Carboplatin |
| Arm 4 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006), Drug: Bevacizumab, Drug: Paclitaxel, Drug: Carboplatin |
| Arm 5 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006), Drug: Bevacizumab, Drug: Paclitaxel, Drug: Carboplatin |
| Arm 6 | Experimental | Drug: Nexavar (Sorafenib, BAY43-9006), Drug: Bevacizumab, Drug: Paclitaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have Stage IIIB (with malignant pleural effusions) or Stage IV histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
- Age >/= 18 years old
- Patients must have at least 1 evaluable lesion. Lesions must be evaluated by CT scan or MRI
- ECOG Performance Status of 0 to 1
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
Key exclusion criteria (6 listed)
- Patients with squamous histology
- Cardiac disease: Congestive heart failure > Class II NYHA; active coronary artery disease (MI more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management
- HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> Grade 2 NCI-CTC Version 3.0)
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 |
|---|---|---|
| Nexavar (Sorafenib, BAY43-9006)Sorafenib 200 mg orally BID interrupted dosing | Drug | Arm 1, Arm 2 |
| Nexavar (Sorafenib, BAY43-9006)Sorafenib 400 mg orally BID interrupted dosing | Drug | Arm 3, Arm 4, Arm 5, Arm 6 |
| BevacizumabBevacizumab 2.5 mg/kg intravenously | Drug | Arm 3 |
| BevacizumabBevacizumab 5 mg/kg intravenously | Drug | Arm 1, Arm 4 |
| BevacizumabBevacizumab 7.5 mg/kg intravenously | Drug | Arm 5 |
| BevacizumabBevacizumab 10 mg/kg intravenously | Drug | Arm 2, Arm 6 |
| PaclitaxelPaclitaxel 200 mg/m² intravenously | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| CarboplatinCarboplatin AUC 6 intravenously | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab
Time frame: 2 years
1 secondary outcome
The secondary objectives include evaluation of pharmacokinetics, biomarkers, pharmacodynamics and tumor response of patients treated with BAY43-9006 (sorafenib) in combination with bevacizumab, paclitaxel and carboplatin
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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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.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nexavar (Sorafenib, BAY43-9006), Bevacizumab and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung and Lung Cancer, run by Bayer at 2 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 14 inclusion and 6 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to define the safety profile and maximum tolerated dose (MTD) of BAY43-9006 (sorafenib) administered in combination with, carboplatin, paclitaxel and bevacizumab (time frame: 2 years). 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 13 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.