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A Study of ASA404 or Placebo in Combination With Docetaxel in Second-line Treatment for (Stage IIIb/IV) Non-small Cell Lung Cancer (ATTRACT-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00738387
Recruitment Status : Terminated
First Posted : August 20, 2008
Last Update Posted : February 2, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: ASA404 Drug: Placebo Drug: docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients With Locally Advanced or Metastatic (Stage IIIb/IV) Non-small Cell Lung Cancer (NSCLC)
Study Start Date : December 2008
Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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

Drug: ASA404
1800 mg/m2 of ASA404 i.v. on day 1 of each 21 day cycle
Drug: docetaxel
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days
Placebo Comparator: 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

Drug: Placebo
Placebo i.v. on day 1 of each 21 day cycle
Drug: docetaxel
75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days

Primary Outcome Measures :
  1. Overall survival [ Time Frame: Every 6 weeks from study treatment discontinuation until death or loss to follow-up ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Every 6 weeks from study treatment discontinuation until documented PD, death or loss to follow-up ]
  2. Overall response rate [ Time Frame: Every 42 days (=/- 7 days) from date of randomization until PD ]
  3. Quality of life [ Time Frame: At every odd cycle and at end of treatment ]
  4. Biomarker assessments [ Time Frame: 1 hr post-study drug at cycles 1, 2, 4, 6 and End of Treatment ]
  5. Pharmacokinetic assessments [ Time Frame: 1 hr post-study drug, optional 3-5 hr post-study drug at cycles 1, 2, 3, 4, 5 and 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.)
  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:

  1. 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).
  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 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.

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738387

  Hide Study Locations
United States, Alabama
Oncology Specialist, P.c.
Huntsville, Alabama, United States, 35805
United States, Arizona
Arizona Oncology
Tucson, Arizona, United States, 85704
United States, Arkansas
Highlands Oncology Group
Bentonville, Arkansas, United States, 72712
United States, California
Central Hematology Oncology Medical Group
Alhambra, California, United States, 91801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Compassionate Cancer Care Medical Group
Corona, California, United States, 92879
Compassionate Cancer Care Medical Group
Fountain Valley, California, United States, 92708
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
Beaver Medical Group, L.P.
Highland, California, United States, 92346
Scripps Clinic
La Jolla, California, United States, 92037
University of Southern Californa
Los Angeles, California, United States, 90033-0800
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Los Angeles, California, United States, 90095
North Valley Hematology/Oncology Medical Group
Northridge, California, United States, 91325
University of California Irvine Medical Center
Orange, California, United States, 92868
Ventura County Hematology/Oncology Specialists
Oxnard, California, United States, 93030
Palo Alto Medical Foundation - Camino Div.
Palo Alto, California, United States, 94301
Bay Area Cancer Research Group
Pleasant Hill, California, United States, 94523
Loma Linda Oncology Medical Group, Inc.
Redlands, California, United States, 92374
Compassionate Cancer Care Medical Group
Riverside, California, United States, 92501
California Pacific Medical Research Institute
San Francisco, California, United States, 94115
University of California - SF
San Francisco, California, United States, 94115
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 21113
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
Ocala Oncology Center
Ocala, Florida, United States, 34474
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Cancer Centers of Florida, PA
Orlando, Florida, United States, 32806
Hematology/Oncology Associates of Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Georgia
Suburban Hematology-Oncology
Lawrenceville, Georgia, United States, 30045
United States, Illinois
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States, 62526
Comprehensive Cancer Program
Harvey, Illinois, United States, 60426
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
OSF Center for Cancer Care
Rockford, Illinois, United States, 61108-2472
Loyola Cancer Care and Research Center
Winfield, Illinois, United States, 60190
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Iowa
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Kansas City Cancer care, Southwest
Overland Park, Kansas, United States, 66210
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
Cancer Center of Texas
Wichita, Kansas, United States, 67214
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Western Kentucky Hematology & Oncology
Paducah, Kentucky, United States, 42003
United States, Maryland
Harry & Jeannette Weinberg Cancer Institute
Baltimore, Maryland, United States, 21237
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Mexico
New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87109
United States, New York
Advanced Oncology Associates
Armonk, New York, United States, 10504
Arena Oncology Associates, P.C.
Lake Success, New York, United States, 11042
NY Oncology/Hematology - Latham
Latham, New York, United States, 12110
Winthrop Hematology/Oncology
Mineola, New York, United States, 11501
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Cancer Center of North Carolina
Raleigh, North Carolina, United States, 27606
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, United States, 45042
United States, Oregon
Kaiser Permanante, Northwest Region
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Luke's Hospital & Healtth Network
Bethlehem, Pennsylvania, United States, 18015
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Cancer center - Abilene
Abilene, Texas, United States, 79606
Texas Oncology - Arlington South
Arlington, Texas, United States, 76014-2084
Mamie McFadden Ward Cancer Ctr, Texas Oncology
Beaumont, Texas, United States, 77702-1449
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Texas Oncology at Presbyterian Hospital
Dallas, Texas, United States, 75231
Methodist Charlton Cancer Center
Dallas, Texas, United States, 75237
UT Southwester Med Ctr at Dallas
Dallas, Texas, United States, 75390
Texas Cancer Center - Denton
Denton, Texas, United States, 76210
Longview Cancer Center
Longview, Texas, United States, 75601
Texas Oncology - Allison Cancer Center
Midland, Texas, United States, 79701
Paris Regional Cancer Center
Paris, Texas, United States, 75460
Texas Cancer Center - Sherman
Sherman, Texas, United States, 75090
Tyler Cancer Center
Tyler, Texas, United States, 75702
Blood and Cancer Center of East Texas
Tyler, Texas, United States, 75791
Texas Oncology Cancer Care Center & Research Center
Waco, Texas, United States, 76712
United States, Washington
Puget Sound Cancer Centers
Edmonds, Washington, United States, 98026
Fred Hutchinson Cancer Reseach Center
Seattle, Washington, United States, 98109
Puget Sound Cancer Center
Seattle, Washington, United States, 98133
Evergreen Hematology and Oncology
Spokane, Washington, United States, 99218
MultiCare Health System
Tacoma, Washington, United States, 98405
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Novartis Investigative Site
Antwerpen, Belgium
Novartis Investigative Site
Arlon, Belgium
Novartis Investigative Site
Bruxelles, Belgium
Novartis Investigative Site
Genk, Belgium
Novartis Investigative Site
Gent, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Liege, 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-Rivieres, 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 Cedex 5, France
Novartis Investigative Site
Caen Cedex 9, France
Novartis Investigative Site
La Chaussée Saint Victor, France
Novartis Investigative Site
Le mans Cedex, France
Novartis Investigative Site
Lille Cedex, France
Novartis Investigative Site
Nimes, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Perpignan, France
Novartis Investigative Site
Rennes cedex 5, France
Novartis Investigative Site
Vandoeuvre-les-Nancy, France
Novartis Investigative site
Bamberg, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Coswig, Germany
Novartis Investigative Site
Eschweiler, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Freiburg, Germany
Novartis Investigative Site
Grosshansdorf, Germany
Novartis Investigative Site
Guestrow, Germany
Novartis Investigative Site
Halle, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hannover, Germany
Novartis Investigative Site
Hemer, Germany
Novartis Investigative Site
Koeln, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Magdeburg, Germany
Novartis Investigative Site
Muenchen, Germany
Novartis Investigative Site
Muenster, Germany
Novartis Investigative Site
Oldenburg, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative site
Deszk, Hungary
Novartis Investigative Site
Gyula, Hungary
Novartis Investigative Site
Szekesfehervar, Hungary
Novartis Investigative Site
Torokbalint, 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
Milano, 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
Warszawa, Poland
Novartis Investigative Site
Mataro, Spain
Novartis investigative Site
Sabadell, Spain
Novartis Investigative Site
Santander, Spain
Novartis Investigative Site
Geneve, Switzerland
Novartis Investigative site
St. Gallen, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00738387     History of Changes
Other Study ID Numbers: CASA404A2302
EUDRACT number: 2008-002309-38
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Tumor vascular disrupting agent
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action