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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)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01069328
First received: February 15, 2010
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Lung Cancer
 Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Carboplatin
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: July 2006
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
Drug: Bevacizumab
Bevacizumab 5 mg/kg intravenously
Drug: Paclitaxel
Paclitaxel 200 mg/m² intravenously
Drug: Carboplatin
Carboplatin AUC 6 intravenously
Experimental: Arm 2 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 200 mg orally BID interrupted dosing
Drug: Bevacizumab
Bevacizumab 10 mg/kg intravenously
Drug: Paclitaxel
Paclitaxel 200 mg/m² intravenously
Drug: Carboplatin
Carboplatin AUC 6 intravenously
Experimental: Arm 3 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Drug: Bevacizumab
Bevacizumab 2.5 mg/kg intravenously
Drug: Paclitaxel
Paclitaxel 200 mg/m² intravenously
Drug: Carboplatin
Carboplatin AUC 6 intravenously
Experimental: Arm 4 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Drug: Bevacizumab
Bevacizumab 5 mg/kg intravenously
Drug: Paclitaxel
Paclitaxel 200 mg/m² intravenously
Drug: Carboplatin
Carboplatin AUC 6 intravenously
Experimental: Arm 5 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Drug: Bevacizumab
Bevacizumab 7.5 mg/kg intravenously
Drug: Paclitaxel
Paclitaxel 200 mg/m² intravenously
Drug: Carboplatin
Carboplatin AUC 6 intravenously
Experimental: Arm 6 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400 mg orally BID interrupted dosing
Drug: Bevacizumab
Bevacizumab 10 mg/kg intravenously
Drug: Paclitaxel
Paclitaxel 200 mg/m² intravenously
Drug: Carboplatin
Carboplatin AUC 6 intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069328

Locations
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, BayerHealthcare Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01069328     History of Changes
Other Study ID Numbers: 11956
Study First Received: February 15, 2010
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Lung
cancer
NSCLC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion, Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pleural Neoplasms
 Pleural Effusion
Pleural Diseases
Bevacizumab
Sorafenib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013