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

Completed · Phase 1

Conditions studied: Carcinoma, Non-Small-Cell Lung, Lung Cancer

In brief

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

Key facts

Study ID

NCT01069328

Run by

Bayer

People needed

33

Starts

2006-07-01

Expected to finish

2011-10-01

Last updated by the study team

2013-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Rochester, Minnesota, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.