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CompletedNCT01069328Updated Nov 13, 2013

Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)

A Phase 1 interventional study of Nexavar (Sorafenib, BAY43-9006) and Nexavar (Sorafenib, BAY43-9006) in Carcinoma, Non-Small-Cell Lung and Lung Cancer, sponsored by Bayer. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-13.

Sponsored by Bayer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer

Keywords

  • Lung
  • cancer
  • NSCLC
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 33 is below the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
    • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Nexavar (Sorafenib, BAY43-9006) · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin

  • Experimental
    Arm 2

    Drug: Nexavar (Sorafenib, BAY43-9006) · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin

  • Experimental
    Arm 3

    Drug: Nexavar (Sorafenib, BAY43-9006) · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin

  • Experimental
    Arm 4

    Drug: Nexavar (Sorafenib, BAY43-9006) · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin

  • Experimental
    Arm 5

    Drug: Nexavar (Sorafenib, BAY43-9006) · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin

  • Experimental
    Arm 6

    Drug: Nexavar (Sorafenib, BAY43-9006) · Drug: Bevacizumab · Drug: Paclitaxel · Drug: Carboplatin

Interventions

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 2 years

07

Study locations

2 sites
  • Rochester, Minnesota 55905, United States
  • Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01069328
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 17, 2010
Start date
Jul 2006
Primary completion
Sep 2011
Completion
Oct 2011
Last update
Nov 13, 2013

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Sorafenib · Bevacizumab · Paclitaxel · Carboplatin

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