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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Lung Cancer

Thank you

Trial Information

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)


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
- 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

11956

NCT ID:

NCT01069328

Start Date:

July 2006

Completion Date:

October 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Lung
  • cancer
  • NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion, Malignant

Name

Location

Alexandria, Minnesota  56308
Austin, Texas  78705