Clinical trial · Interventional
Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)
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)
NCT01069328CI-TRIAL-00012626completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Nexavar (Sorafenib, BAY43-9006) | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Nexavar (Sorafenib, BAY43-9006)
- Drug: Bevacizumab
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: Nexavar (Sorafenib, BAY43-9006)
- Drug: Bevacizumab
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Arm 3
- interventionNames
- Drug: Nexavar (Sorafenib, BAY43-9006)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.