check_circleStudy Completed

Carcinoma, Non-Small-Cell Lung, Lung Cancer

Bayer Identifier:

11956

ClinicalTrials.gov Identifier:

NCT01069328

EudraCT Number:

Not Available

EU CT Number:

Not Available
Dose escalating study with BAY43-9006 with carboplatin, paclitaxel and bevacizumab in untreated stage IIIb non-small cell lung cancer (NSCLC)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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  -- ALT and AST  -- INR  -- Serum creatinine /= 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
  • - 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 summary

Enrollment Goal
33
Trial Dates
July 2006 - October 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States
Completed
Mayo Clinic - RochesterRochester, 55905, United States

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
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    yes

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
    date_rangeTime Frame:
    2 years
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.