Study 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

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
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

Trial Dates

July 2006 - October 2011

Phase

Phase 1

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	M. D. Anderson Cancer Center - University of Texas	Houston, 77030, United States
Completed	Mayo Clinic - Rochester	Rochester, 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
Time Frame:
2 years
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
Time Frame:
2 years
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

Additional Information

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