Lung Cancer Clinical Trial
A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer
Summary
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
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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%]
Any clinically significant cardiac abnormality as assessed by the investigator
Patients who are currently receiving treatment with any medications that have the potential to prolong QT interval or are known to have a risk of causing Torsades de Pointes (See Section 6.8.5.1 and Appendix 2) which cannot be either safely discontinued or switched to a different medication prior to starting study drug administration must be discussed with and approved by the Novartis Global Clinical team prior to randomization.
Known allergy or hypersensitivity to docetaxel or drugs formulated with polysorbate 80
Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
Pregnant or breast feeding females
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)
• Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions while taking docetaxel and therefore are not considered effective contraceptive methods for this study when used as a single agent. Therefore, it is highly recommended that a concomitant barrier method be used with oral, implantable, or injectable contraceptives. The investigator shall counsel the patient accordingly. Women of childbearing potential must have a negative pregnancy test (serum or urine) 72 hours prior to administration of study treatment. For a list of substrates of human liver microsomal P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)
Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
Significant neurologic or psychiatric disorder which could compromise participation in the study
Patient unwilling or unable to comply with the protocol
Patients receiving full-dose therapeutic oral or parenteral anticoagulation are ineligible. Patients receiving thrombolytic therapy within 10 days of starting are also ineligible.
Other protocol-defined inclusion/exclusion criteria may apply
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There are 87 Locations for this study
Huntsville Alabama, 35805, United States
Tucson Arizona, 85704, United States
Bentonville Arkansas, 72712, United States
Alhambra California, 91801, United States
Bakersfield California, 93309, United States
Corona California, 92879, United States
Fountain Valley California, 92708, United States
Fullerton California, 92835, United States
Highland California, 92346, United States
La Jolla California, 92037, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Northridge California, 91325, United States
Orange California, 92868, United States
Oxnard California, 93030, United States
Palo Alto California, 94301, United States
Pleasant Hill California, 94523, United States
Redlands California, 92374, United States
Riverside California, 92501, United States
San Francisco California, 94115, United States
San Francisco California, 94115, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Washington District of Columbia, 21113, United States
Miami Florida, 33176, United States
New Port Richey Florida, 34655, United States
Ocala Florida, 34474, United States
Orlando Florida, 32804, United States
Orlando Florida, 32806, United States
Port Saint Lucie Florida, 34952, United States
Lawrenceville Georgia, 30045, United States
Decatur Illinois, 62526, United States
Harvey Illinois, 60426, United States
Niles Illinois, 60714, United States
Rockford Illinois, 61108, United States
Winfield Illinois, 60190, United States
Indianapolis Indiana, 46219, United States
Lafayette Indiana, 47905, United States
Terre Haute Indiana, 47802, United States
Sioux City Iowa, 51101, United States
Overland Park Kansas, 66210, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40202, United States
Paducah Kentucky, 42003, United States
Baltimore Maryland, 21237, United States
Columbia Missouri, 65201, United States
Saint Louis Missouri, 63141, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89135, United States
Albuquerque New Mexico, 87109, United States
Armonk New York, 10504, United States
Lake Success New York, 11042, United States
Latham New York, 12110, United States
Mineola New York, 11501, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Raleigh North Carolina, 27606, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43235, United States
Middletown Ohio, 45042, United States
Portland Oregon, 97227, United States
Bethlehem Pennsylvania, 18015, United States
Philadelphia Pennsylvania, 19140, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37203, United States
Abilene Texas, 79606, United States
Arlington Texas, 76014, United States
Beaumont Texas, 77702, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75237, United States
Dallas Texas, 75390, United States
Denton Texas, 76210, United States
Longview Texas, 75601, United States
Midland Texas, 79701, United States
Paris Texas, 75460, United States
Sherman Texas, 75090, United States
Tyler Texas, 75702, United States
Tyler Texas, 75791, United States
Waco Texas, 76712, United States
Edmonds Washington, 98026, United States
Seattle Washington, 98109, United States
Seattle Washington, 98133, United States
Spokane Washington, 99218, United States
Tacoma Washington, 98405, United States
Vancouver Washington, 98684, United States
Antwerpen , , Belgium
Arlon , , Belgium
Bruxelles , , Belgium
Genk , , Belgium
Gent , , Belgium
Leuven , , Belgium
Liege , , Belgium
Namur , , Belgium
Edmonton , , Canada
Greenfield Park , , Canada
Laval , , Canada
Montreal , , Canada
Toronto , , Canada
Trois-Rivieres , , Canada
Vancouver , , Canada
Weston , , Canada
Winnepeg , , Canada
Avignon , , France
Brest , , France
Caen Cedex 5 , , France
Caen Cedex 9 , , France
La Chaussée Saint Victor , , France
Le mans Cedex , , France
Lille Cedex , , France
Nimes , , France
Paris , , France
Perpignan , , France
Rennes cedex 5 , , France
Vandoeuvre-les-Nancy , , France
Bamberg , , Germany
Berlin , , Germany
Coswig , , Germany
Eschweiler , , Germany
Essen , , Germany
Freiburg , , Germany
Grosshansdorf , , Germany
Guestrow , , Germany
Halle , , Germany
Hamburg , , Germany
Hannover , , Germany
Hemer , , Germany
Koeln , , Germany
Leipzig , , Germany
Magdeburg , , Germany
Muenchen , , Germany
Muenster , , Germany
Oldenburg , , Germany
Ulm , , Germany
Deszk , , Hungary
Gyula , , Hungary
Szekesfehervar , , Hungary
Torokbalint , , Hungary
Zalaegerszeg-Pozva , , Hungary
Ancona , , Italy
Aviano , , Italy
Bologna , , Italy
Cosenza , , Italy
Cremona , , Italy
Milano , , Italy
Mirano , , Italy
Monza , , Italy
Napoli , , Italy
Palermo , , Italy
Reggio Emilia , , Italy
Sassari , , Italy
Udine , , Italy
Bialystok , , Poland
Lonza , , Poland
Szczecin , , Poland
Warszawa , , Poland
Mataro , , Spain
Sabadell , , Spain
Santander , , Spain
Geneve , , Switzerland
St. Gallen , , Switzerland
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