Trial Condition(s):

Carcinoma, Non-Small-Cell Lung, Lung Cancer

Dose escalating study with BAY43-9006 with carboplatin, paclitaxel and bevacizumab in untreated stage IIIb non-small cell lung cancer (NSCLC)

Bayer Identifier:

11956

ClinicalTrials.gov Identifier:

NCT01069328

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
33
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

M. D. Anderson Cancer Center - University of Texas

Houston, United States, 77030

Status
Completed
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Completed
 

Trial Design