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Non-Small Cell Lung CancerPhase 3ATTRACT-2NCT00738387

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

A Phase 3 study testing ASA404 and docetaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 162 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
ASA404 and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
162 sitesin 10 countries
Study dates
Dec 2008to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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

Who cannot join

  • 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
Show all 38Show fewer
  • 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

Trial locations and contacts

162 sites in 10 countries.

162 sites in 10 countries

United States88 sites

  • Texas Cancer center - Abilene

    Abilene, Texas, 79606

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Central Hematology Oncology Medical Group

    Alhambra, California, 91801

  • Texas Oncology - Arlington South

    Arlington, Texas, 76014-2084

  • Advanced Oncology Associates

    Armonk, New York, 10504

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Harry & Jeannette Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Mamie McFadden Ward Cancer Ctr, Texas Oncology

    Beaumont, Texas, 77702-1449

  • Highlands Oncology Group

    Bentonville, Arkansas, 72712

  • St. Luke's Hospital & Healtth Network

    Bethlehem, Pennsylvania, 18015

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Hematology Oncology Consultants, Inc.

    Columbus, Ohio, 43235

  • Compassionate Cancer Care Medical Group

    Corona, California, 92879

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology at Presbyterian Hospital

    Dallas, Texas, 75231

  • Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • UT Southwester Med Ctr at Dallas

    Dallas, Texas, 75390

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Texas Cancer Center - Denton

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Puget Sound Cancer Centers

    Edmonds, Washington, 98026

  • Compassionate Cancer Care Medical Group

    Fountain Valley, California, 92708

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Comprehensive Cancer Program

    Harvey, Illinois, 60426

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Beaver Medical Group, L.P.

    Highland, California, 92346

  • Oncology Specialist, P.c.

    Huntsville, Alabama, 35805

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Scripps Clinic

    La Jolla, California, 92037

  • Horizon Oncology Center

    Lafayette, Indiana, 47905

  • Arena Oncology Associates, P.C.

    Lake Success, New York, 11042

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • NY Oncology/Hematology - Latham

    Latham, New York, 12110

  • Suburban Hematology-Oncology

    Lawrenceville, Georgia, 30045

  • Longview Cancer Center

    Longview, Texas, 75601

  • University of Southern Californa

    Los Angeles, California, 90033-0800

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Signal Point Hematology/Oncology, Inc.

    Middletown, Ohio, 45042

  • Texas Oncology - Allison Cancer Center

    Midland, Texas, 79701

  • Winthrop Hematology/Oncology

    Mineola, New York, 11501

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • North Valley Hematology/Oncology Medical Group

    Northridge, California, 91325

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Cancer Centers of Florida, PA

    Orlando, Florida, 32806

  • Kansas City Cancer care, Southwest

    Overland Park, Kansas, 66210

  • Ventura County Hematology/Oncology Specialists

    Oxnard, California, 93030

  • Western Kentucky Hematology & Oncology

    Paducah, Kentucky, 42003

  • Palo Alto Medical Foundation - Camino Div.

    Palo Alto, California, 94301

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Bay Area Cancer Research Group

    Pleasant Hill, California, 94523

  • Hematology/Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Kaiser Permanante, Northwest Region

    Portland, Oregon, 97227

  • Cancer Center of North Carolina

    Raleigh, North Carolina, 27606

  • Loma Linda Oncology Medical Group, Inc.

    Redlands, California, 92374

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

  • OSF Center for Cancer Care

    Rockford, Illinois, 61108-2472

  • California Pacific Medical Research Institute

    San Francisco, California, 94115

  • University of California - SF

    San Francisco, California, 94115

  • Fred Hutchinson Cancer Reseach Center

    Seattle, Washington, 98109

  • Puget Sound Cancer Center

    Seattle, Washington, 98133

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Evergreen Hematology and Oncology

    Spokane, Washington, 99218

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Stanford Cancer Center

    Stanford, California, 94305

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • MultiCare Health System

    Tacoma, Washington, 98405

  • Providence Medical Group

    Terre Haute, Indiana, 47802

  • Arizona Oncology

    Tucson, Arizona, 85704

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Blood and Cancer Center of East Texas

    Tyler, Texas, 75791

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

  • Texas Oncology Cancer Care Center & Research Center

    Waco, Texas, 76712

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 21113

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

  • Cancer Center of Texas

    Wichita, Kansas, 67214

  • Loyola Cancer Care and Research Center

    Winfield, Illinois, 60190

Other trials in United States

Germany19 sites

  • Novartis Investigative site

    Bamberg

  • Novartis Investigative Site

    Berlin

  • Novartis Investigative Site

    Cologne

  • Novartis Investigative Site

    Coswig

  • Novartis Investigative Site

    Eschweiler

  • Novartis Investigative Site

    Essen

  • Novartis Investigative Site

    Freiburg im Breisgau

  • Novartis Investigative Site

    Großhansdorf

  • Novartis Investigative Site

    Güstrow

  • Novartis Investigative Site

    Halle

  • Novartis Investigative Site

    Hamburg

  • Novartis Investigative Site

    Hanover

  • Novartis Investigative Site

    Hemer

  • Novartis Investigative Site

    Leipzig

  • Novartis Investigative Site

    Magdeburg

  • Novartis Investigative Site

    München

  • Novartis Investigative Site

    Münster

  • Novartis Investigative Site

    Oldenburg

  • Novartis Investigative Site

    Ulm

Other trials in Germany

Italy13 sites

  • Novartis Investigative Site

    Ancona

  • Novartis Investigative Site

    Aviano

  • Novartis Investigative Site

    Bologna

  • Novartis Investigative Site

    Cosenza

  • Novartis Investigative Site

    Cremona

  • Novartis Investigative Site

    Milan

  • Novartis Investigative Site

    Mirano

  • Novartis Investigative Site

    Monza

  • Novartis Investigative Site

    Naples

  • Novartis Investigative Site

    Palermo

  • Novartis Investigative Site

    Reggio Emilia

  • Novartis Investigative Site

    Sassari

  • Novartis InvestigativeSite

    Udine

Other trials in Italy

France11 sites

  • Novartis Investigative Site

    Avignon

  • Novartis Investigative Site

    Brest

  • Novartis Investigative Site

    Caen

  • Novartis Investigative Site

    La Chaussée-Saint-Victor

  • Novartis Investigative Site

    Le Mans

  • Novartis Investigative Site

    Lille

  • Novartis Investigative Site

    Nîmes

  • Novartis Investigative Site

    Paris

  • Novartis Investigative Site

    Perpignan

  • Novartis Investigative Site

    Rennes

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy

Other trials in France

Canada9 sites

  • Novartis Investigative Site

    Edmonton

  • Novartis Investigative Site

    Greenfield Park

  • Novartis Investigative Site

    Laval

  • Novartis Investigative Site

    Montreal

  • Novartis Investigative Site

    Toronto

  • Novartis Investigative Site

    Trois-Rivières

  • Novartis Investigative Site

    Vancouver

  • Novartis Investigative Site

    Weston

  • Novartis Investigative Site

    Winnepeg

Other trials in Canada

Belgium8 sites

  • Novartis Investigative Site

    Antwerp

  • Novartis Investigative Site

    Arlon

  • Novartis Investigative Site

    Brussels

  • Novartis Investigative Site

    Genk

  • Novartis Investigative Site

    Ghent

  • Novartis Investigative Site

    Leuven

  • Novartis Investigative Site

    Liège

  • Novartis Investigative Site

    Namur

Other trials in Belgium

Hungary5 sites

  • Novartis Investigative site

    Deszk

  • Novartis Investigative Site

    Gyula

  • Novartis Investigative Site

    Székesfehérvár

  • Novartis Investigative Site

    Törökbálint

  • Novartis Investigative Site

    Zalaegerszeg-Pozva

Other trials in Hungary

Poland4 sites

  • Novartis Investigative Site

    Bialystok

  • Novartis Investigative Site

    Lonza

  • Novartis Investigative Site

    Szczecin

  • Novartis Investigative Site

    Warsaw

Other trials in Poland

Spain3 sites

  • Novartis Investigative Site

    Mataró

  • Novartis investigative Site

    Sabadell

  • Novartis Investigative Site

    Santander

Other trials in Spain

Switzerland2 sites

  • Novartis Investigative Site

    Geneva

  • Novartis Investigative site

    Sankt Gallen

Other trials in Switzerland

About this study

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)

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

Being tested
ASA404, Placebo, docetaxel
Keywords
Tumor vascular disrupting agent, VDA, ASA404, non-small cell lung cancer, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASA404Drug

    1800 mg/m2 of ASA404 i.v. on day 1 of each 21 day cycle

  • PlaceboDrug

    Placebo i.v. on day 1 of each 21 day cycle

  • docetaxelDrug

    75 mg/m2 of docetaxel intravenous (IV) an hour for 1st 6 cycles; cycle: every 21 days

Study groups in NCT00738387
Study groupRoleWhat they receive
ASA404 + docetaxelExperimental1800 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
Receives: Drug: ASA404; Drug: docetaxel
Placebo + docetaxelPlacebo comparatorPlacebo 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
Receives: Drug: Placebo; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Every 6 weeks from study treatment discontinuation until death or loss to follow-up

Secondary outcomes (5)

  1. Progression free survival

    Measured: Every 6 weeks from study treatment discontinuation until documented PD, death or loss to follow-up

  2. Overall response rate

    Measured: Every 42 days (=/- 7 days) from date of randomization until PD

  3. Quality of life

    Measured: At every odd cycle and at end of treatment

  4. Biomarker assessments

    Measured: 1 hr post-study drug at cycles 1, 2, 4, 6 and End of Treatment

  5. Pharmacokinetic assessments

    Measured: 1 hr post-study drug, optional 3-5 hr post-study drug at cycles 1, 2, 3, 4, 5 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738387
Sponsor's protocol ID
CASA404A2302
Other IDs
EUDRACT number: 2008-002309-38
Acronym
ATTRACT-2
Status last verified
May 2012
First submitted
19 Aug 2008
Last updated
24 Dec 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ASA404 and docetaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 162 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Germany, Italy, France, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Every 6 weeks from study treatment discontinuation until death or loss to follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00738387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.

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