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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01069328
First received: February 15, 2010
Last updated: November 14, 2012
Last verified: November 2012
History of Changes

February 15, 2010
November 14, 2012
July 2006
September 2011   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01069328 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Drug: Nexavar (Sorafenib, BAY43-9006)
    Sorafenib 200 mg orally BID interrupted dosing
  • Drug: Nexavar (Sorafenib, BAY43-9006)
    Sorafenib 400 mg orally BID interrupted dosing
  • Drug: Bevacizumab
    Bevacizumab 2.5 mg/kg intravenously
  • Drug: Bevacizumab
    Bevacizumab 5 mg/kg intravenously
  • Drug: Bevacizumab
    Bevacizumab 7.5 mg/kg intravenously
  • Drug: Bevacizumab
    Bevacizumab 10 mg/kg intravenously
  • Drug: Paclitaxel
    Paclitaxel 200 mg/m² intravenously
  • Drug: Carboplatin
    Carboplatin AUC 6 intravenously
  • Experimental: Arm 1
    Interventions:
    • Drug: Nexavar (Sorafenib, BAY43-9006)
    • Drug: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: Arm 2
    Interventions:
    • Drug: Nexavar (Sorafenib, BAY43-9006)
    • Drug: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: Arm 3
    Interventions:
    • Drug: Nexavar (Sorafenib, BAY43-9006)
    • Drug: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: Arm 4
    Interventions:
    • Drug: Nexavar (Sorafenib, BAY43-9006)
    • Drug: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: Arm 5
    Interventions:
    • Drug: Nexavar (Sorafenib, BAY43-9006)
    • Drug: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Experimental: Arm 6
    Interventions:
    • Drug: Nexavar (Sorafenib, BAY43-9006)
    • Drug: Bevacizumab
    • Drug: Paclitaxel
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
October 2011
September 2011   (final data collection date for primary outcome measure)

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:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069328
11956
No
Head Clinical Pharmacology, BayerHealthcare Pharmaceuticals Inc
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP