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

NCT01069328 | Completed Phase 1

• 1 other identifier: 11956
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Cancer

Keywords

Lung; cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (6)

Arm 1

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Arm 2

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Arm 3

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Arm 4

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Arm 5

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Arm 6

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Nexavar (Sorafenib, BAY43-9006) DRUG

Sorafenib 200 mg orally BID interrupted dosing

Arm 1; Arm 2

Bevacizumab DRUG

Bevacizumab 2.5 mg/kg intravenously

Arm 3

Paclitaxel DRUG

Paclitaxel 200 mg/m² intravenously

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Carboplatin DRUG

Carboplatin AUC 6 intravenously

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasms

Interventions

Sorafenib; Bevacizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: July 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (2)