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

Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069328
• Other study ID #: 11956
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2010
• Last updated: November 12, 2013
• Start date: July 2006
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
• Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
• Bevacizumab
Bevacizumab 2.5 mg/kg intravenously
• Bevacizumab
Bevacizumab 5 mg/kg intravenously
• Bevacizumab
Bevacizumab 7.5 mg/kg intravenously
• Bevacizumab
Bevacizumab 10 mg/kg intravenously
• Paclitaxel
Paclitaxel 200 mg/m² intravenously
• Carboplatin
Carboplatin AUC 6 intravenously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	Yes
Secondary	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		2 years	Yes

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