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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung; Lung Cancer
• Interventions: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT01069328
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Paclitaxel	-
Arm 3	Carboplatin	-
Arm 1	Nexavar (Sorafenib, BAY43-9006)	-
Arm 1	Bevacizumab	-
Arm 2	Nexavar (Sorafenib, BAY43-9006)	-
Arm 3	Nexavar (Sorafenib, BAY43-9006)	-
Arm 4	Nexavar (Sorafenib, BAY43-9006)	-
Arm 5	Nexavar (Sorafenib, BAY43-9006)	-
Arm 6	Nexavar (Sorafenib, BAY43-9006)	-
Arm 5	Bevacizumab	-
Arm 1	Paclitaxel	-
Arm 1	Carboplatin	-
Arm 2	Carboplatin	-
Arm 2	Bevacizumab	-
Arm 2	Paclitaxel	-
Arm 3	Bevacizumab	-
Arm 4	Carboplatin	-
Arm 4	Bevacizumab	-
Arm 4	Paclitaxel	-
Arm 5	Paclitaxel	-
Arm 5	Carboplatin	-
Arm 6	Bevacizumab	-
Arm 6	Paclitaxel	-
Arm 6	Carboplatin	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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