A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with locally advanced or metastatic non-small cell lung cancer

Key facts

Study ID

NCT00738387

Run by

Novartis Pharmaceuticals

People needed

900

Starts

2008-12-01

Last updated by the study team

2020-12-24

Who can join

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

You may qualify if…

• Histologically confirmed non-small cell carcinoma of the lung of all histologies. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.)
• Patients who have progressed while on or following a first-line chemotherapy regimen for Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first-line will be eligible
• Age ≥ 18 years old
• WHO Performance Status of 0-2
• Not applicable per amendment#2
• Central laboratory values within the range, as defined below, within 2 weeks of randomization:
• Absolute neutrophils count (ANC) ≥ 2.0 x 109/L
• Platelets ≥ 100 x109/L
• Hemoglobin ≥ 10 g/dL
• Serum creatinine ≤ 1.5 x ULN
• Serum bilirubin ≤ 1.5 x ULN
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases)
• International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 x ULN
• Electrolyte values (sodium, potassium, calcium, magnesium) within ≥1 x LLN and ≤1 x ULN. Patients with corrected electrolyte values are eligible
• Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing). Any female presenting with a positive or borderline pregnancy test may undergo a gynecological exam and ultra sound to rule out pregnancy and if found to be negative may be included in the trial.
• Life expectancy ≥ 12 weeks
• Written informed consent obtained according to local guidelines

You may not qualify if…

• Patients having CNS metastases (patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed).
• Patients with concurrent malignancy, or history or prior malignancy within the past two years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer.
• Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all acute radiotherapy-related toxicities.
• Major surgery must be completed 4 weeks prior to starting study treatment. Major surgery is defined at the investigator's discretion. Insertion of a vascular access device is not considered major or minor surgery. Patients must have recovered from all acute surgery-related complications.
• Treatment with all prior anticancer therapies ≤ 3 weeks prior to randomization (≤ 6 weeks for bevacizumab, mitomycin and nitrosoureas)
• Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
• Prior treatment with docetaxel for NSCLC in the locally advanced or metastatic first-line setting
• Prior treatment with VDAs or tumor - VDAs
• Any medical condition resulting in ≥ CTC grade 2 dyspnea
• Patients with systolic BP > 160 mm Hg and/or diastolic BP > 90 mm Hg while on medication for hypertension
• Patients with recent hemoptysis associated with NSCLC (>1 teaspoon in a single episode within 4 weeks)
• Patients with any one of the following:
• Patients with long QT syndrome
• Patients with a Baseline 12-lead ECG QTcF of > 450 msec for men or >470 msec for women using the Fridericia [QTcF formula] measurement determined per central ECG evaluation report
• Congestive heart failure (NY Heart Association class III or IV)
• Patients with a myocardial infarction within 12 months of starting study treatment or with implanted cardiac pacemaker
• Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
• History of poorly-controlled hypertension or poor compliance with anti-hypertensive regimen
• History of a sustained ventricular tachycardia
• Presence of atrial tachycardia (e.g., atrial fibrillation, atrial flutter, multifocal atrial tachycardia, supraventricular tachycardia) if not effectively rate-controlled
• History of ventricular fibrillation or Torsades de Pointes (TdP)
• Right bundle branch block (RBBB) and either left anterior hemiblock or left posterior hemiblock (bifasicular block)
• Bradycardia defined as heart rate <50 beats per minute
• [For China only: Patients older than 70 years with evidence of myocardial ischemia by coronary artery angiography or cardiac radionucleotide imaging examination]
• [For China only: Patients with LVEF <=40%]

Where it is running

• Arizona Oncology — Tucson, Arizona, United States
• Highlands Oncology Group — Bentonville, Arkansas, United States
• Central Hematology Oncology Medical Group — Alhambra, California, United States
• Comprehensive Blood and Cancer Center — Bakersfield, California, United States
• Compassionate Cancer Care Medical Group — Corona, California, United States
• Compassionate Cancer Care Medical Group — Fountain Valley, California, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• Beaver Medical Group, L.P. — Highland, California, United States
• Scripps Clinic — La Jolla, California, United States
• University of Southern Californa — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• North Valley Hematology/Oncology Medical Group — Northridge, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Ventura County Hematology/Oncology Specialists — Oxnard, California, United States
• Palo Alto Medical Foundation - Camino Div. — Palo Alto, California, United States
• Bay Area Cancer Research Group — Pleasant Hill, California, United States
• Loma Linda Oncology Medical Group, Inc. — Redlands, California, United States
• Compassionate Cancer Care Medical Group — Riverside, California, United States
• California Pacific Medical Research Institute — San Francisco, California, United States
• University of California - SF — San Francisco, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Oncology Specialist, P.c. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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