A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer
NCT ID: NCT00738387
Last Updated: 2020-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
900 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ASA404 + docetaxel
1800 mg/m2 of ASA404 intravenous (IV) on day 1 of each 21 day cycle
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
ASA404
1800 mg/m2 of ASA404 i.v. on day 1 of each 21 day cycle
docetaxel
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
Placebo + docetaxel
Placebo i.v. on day 1 of each 21 day cycle
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
Placebo
Placebo i.v. on day 1 of each 21 day cycle
docetaxel
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
Interventions
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ASA404
1800 mg/m2 of ASA404 i.v. on day 1 of each 21 day cycle
Placebo
Placebo i.v. on day 1 of each 21 day cycle
docetaxel
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Age ≥ 18 years old
4. WHO Performance Status of 0-2
5. Not applicable per amendment#2
6. 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.
7. Life expectancy ≥ 12 weeks
8. Written informed consent obtained according to local guidelines
Exclusion Criteria
2. 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.
3. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all acute radiotherapy-related toxicities.
4. 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.
5. Treatment with all prior anticancer therapies ≤ 3 weeks prior to randomization (≤ 6 weeks for bevacizumab, mitomycin and nitrosoureas)
6. Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
7. Prior treatment with docetaxel for NSCLC in the locally advanced or metastatic first-line setting
8. Prior treatment with VDAs or tumor - VDAs
9. Any medical condition resulting in ≥ CTC grade 2 dyspnea
10. Patients with systolic BP \> 160 mm Hg and/or diastolic BP \> 90 mm Hg while on medication for hypertension
11. Patients with recent hemoptysis associated with NSCLC (\>1 teaspoon in a single episode within 4 weeks)
12. 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
13. 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.
14. Known allergy or hypersensitivity to docetaxel or drugs formulated with polysorbate 80
15. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
16. 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)
17. 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/)
18. 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).
19. Significant neurologic or psychiatric disorder which could compromise participation in the study
20. Patient unwilling or unable to comply with the protocol
21. Patients receiving full-dose therapeutic oral or parenteral anticoagulation are ineligible. Patients receiving thrombolytic therapy within 10 days of starting are also ineligible.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Hemer, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Magdeburg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Oldenburg, , Germany
Novartis Investigative Site
Ulm, , Germany
Oncology Specialist, P.c.
Huntsville, Alabama, United States
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
Advanced Medical Specialties
Miami, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Cancer Centers of Florida, PA
Orlando, Florida, United States
Hematology/Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States
Suburban Hematology-Oncology
Lawrenceville, Georgia, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States
Comprehensive Cancer Program
Harvey, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States
OSF Center for Cancer Care
Rockford, Illinois, United States
Loyola Cancer Care and Research Center
Winfield, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Horizon Oncology Center
Lafayette, Indiana, United States
Providence Medical Group
Terre Haute, Indiana, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States
Kansas City Cancer care, Southwest
Overland Park, Kansas, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Cancer Center of Texas
Wichita, Kansas, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Western Kentucky Hematology & Oncology
Paducah, Kentucky, United States
Harry & Jeannette Weinberg Cancer Institute
Baltimore, Maryland, United States
Missouri Cancer Associates
Columbia, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
New Mexico Cancer Center
Albuquerque, New Mexico, United States
Advanced Oncology Associates
Armonk, New York, United States
Arena Oncology Associates, P.C.
Lake Success, New York, United States
NY Oncology/Hematology - Latham
Latham, New York, United States
Winthrop Hematology/Oncology
Mineola, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cancer Center of North Carolina
Raleigh, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, United States
Kaiser Permanante, Northwest Region
Portland, Oregon, United States
St. Luke's Hospital & Healtth Network
Bethlehem, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Cancer center - Abilene
Abilene, Texas, United States
Texas Oncology - Arlington South
Arlington, Texas, United States
Mamie McFadden Ward Cancer Ctr, Texas Oncology
Beaumont, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology at Presbyterian Hospital
Dallas, Texas, United States
Methodist Charlton Cancer Center
Dallas, Texas, United States
UT Southwester Med Ctr at Dallas
Dallas, Texas, United States
Texas Cancer Center - Denton
Denton, Texas, United States
Longview Cancer Center
Longview, Texas, United States
Texas Oncology - Allison Cancer Center
Midland, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
Texas Cancer Center - Sherman
Sherman, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Blood and Cancer Center of East Texas
Tyler, Texas, United States
Texas Oncology Cancer Care Center & Research Center
Waco, Texas, United States
Puget Sound Cancer Centers
Edmonds, Washington, United States
Fred Hutchinson Cancer Reseach Center
Seattle, Washington, United States
Puget Sound Cancer Center
Seattle, Washington, United States
Evergreen Hematology and Oncology
Spokane, Washington, United States
MultiCare Health System
Tacoma, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
Novartis Investigative Site
Antwerp, , Belgium
Novartis Investigative Site
Arlon, , Belgium
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Genk, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Namur, , Belgium
Novartis Investigative Site
Edmonton, , Canada
Novartis Investigative Site
Greenfield Park, , Canada
Novartis Investigative Site
Laval, , Canada
Novartis Investigative Site
Montreal, , Canada
Novartis Investigative Site
Toronto, , Canada
Novartis Investigative Site
Trois-Rivières, , Canada
Novartis Investigative Site
Vancouver, , Canada
Novartis Investigative Site
Weston, , Canada
Novartis Investigative Site
Winnepeg, , Canada
Novartis Investigative Site
Avignon, , France
Novartis Investigative Site
Brest, , France
Novartis Investigative Site
Caen, , France
Novartis Investigative Site
La Chaussée-Saint-Victor, , France
Novartis Investigative Site
Le Mans, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Nîmes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Perpignan, , France
Novartis Investigative Site
Rennes, , France
Novartis Investigative Site
Vandœuvre-lès-Nancy, , France
Novartis Investigative site
Bamberg, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Coswig, , Germany
Novartis Investigative Site
Eschweiler, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
Großhansdorf, , Germany
Novartis Investigative Site
Güstrow, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative site
Deszk, , Hungary
Novartis Investigative Site
Gyula, , Hungary
Novartis Investigative Site
Székesfehérvár, , Hungary
Novartis Investigative Site
Törökbálint, , Hungary
Novartis Investigative Site
Zalaegerszeg-Pozva, , Hungary
Novartis Investigative Site
Ancona, , Italy
Novartis Investigative Site
Aviano, , Italy
Novartis Investigative Site
Bologna, , Italy
Novartis Investigative Site
Cosenza, , Italy
Novartis Investigative Site
Cremona, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Mirano, , Italy
Novartis Investigative Site
Monza, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Palermo, , Italy
Novartis Investigative Site
Reggio Emilia, , Italy
Novartis Investigative Site
Sassari, , Italy
Novartis InvestigativeSite
Udine, , Italy
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Lonza, , Poland
Novartis Investigative Site
Szczecin, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Mataró, , Spain
Novartis investigative Site
Sabadell, , Spain
Novartis Investigative Site
Santander, , Spain
Novartis Investigative Site
Geneva, , Switzerland
Novartis Investigative site
Sankt Gallen, , Switzerland
Countries
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Related Links
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Results for CASA404A2302 from the Novartis Clinical Trials Website
Other Identifiers
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EUDRACT number: 2008-002309-38
Identifier Type: -
Identifier Source: secondary_id
CASA404A2302
Identifier Type: -
Identifier Source: org_study_id