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

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Lung Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Nexavar (Sorafenib, BAY43-9006)

Bevacizumab

Paclitaxel

Carboplatin

About this trial

This is an interventional basic science trial for Carcinoma, Non-Small-Cell Lung focused on measuring Lung, cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01069328

First Posted

February 15, 2010

Last Updated

November 12, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01069328

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung, Lung Cancer

Keywords

Lung, cancer, NSCLC

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Experimental

Arm Title

Arm 4

Arm Type

Experimental

Arm Title

Arm 5

Arm Type

Experimental

Arm Title

Arm 6

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Nexavar (Sorafenib, BAY43-9006)

Intervention Description

Sorafenib 200 mg orally BID interrupted dosing

Intervention Type

Drug

Intervention Name(s)

Nexavar (Sorafenib, BAY43-9006)

Intervention Description

Sorafenib 400 mg orally BID interrupted dosing

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab 2.5 mg/kg intravenously

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab 5 mg/kg intravenously

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab 7.5 mg/kg intravenously

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab 10 mg/kg intravenously

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Paclitaxel 200 mg/m² intravenously

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Carboplatin AUC 6 intravenously

Primary Outcome Measure Information:

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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