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

NCT00738387 | Terminated Phase 3

• 2 other identifiers: CASA404A2302EUDRACT number: 2008-002309-38
• Study Type: interventional
• Target: 900
• Locations: 10 countries
• Sites: 162

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

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumor vascular disrupting agent; VDA; ASA404; non-small cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

Secondary Outcomes (5)

• Progression free survival

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

• Overall response rate

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

• Quality of life

  At every odd cycle and at end of treatment

• Biomarker assessments

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

• Pharmacokinetic assessments

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

Study Arms (2)

ASA404 + docetaxel

EXPERIMENTAL

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; Drug: docetaxel

Placebo + docetaxel

PLACEBO COMPARATOR

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; Drug: docetaxel

Interventions

ASA404 DRUG

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

ASA404 + docetaxel

Placebo DRUG

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

Placebo + docetaxel

docetaxel DRUG

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

ASA404 + docetaxel; Placebo + docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (162)

Oncology Specialist, P.c.

Huntsville, Alabama, 35805, United States

Location

Arizona Oncology

Tucson, Arizona, 85704, United States

Location

Highlands Oncology Group

Bentonville, Arkansas, 72712, United States

Location

Central Hematology Oncology Medical Group

Alhambra, California, 91801, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Compassionate Cancer Care Medical Group

Corona, California, 92879, United States

Location

Compassionate Cancer Care Medical Group

Fountain Valley, California, 92708, United States

Location

St. Jude Heritage Healthcare

Fullerton, California, 92835, United States

Location

Beaver Medical Group, L.P.

Highland, California, 92346, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

University of Southern Californa

Los Angeles, California, 90033-0800, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

North Valley Hematology/Oncology Medical Group

Northridge, California, 91325, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Ventura County Hematology/Oncology Specialists

Oxnard, California, 93030, United States

Location

Palo Alto Medical Foundation - Camino Div.

Palo Alto, California, 94301, United States

Location

Bay Area Cancer Research Group

Pleasant Hill, California, 94523, United States

Location

Loma Linda Oncology Medical Group, Inc.

Redlands, California, 92374, United States

Location

Compassionate Cancer Care Medical Group

Riverside, California, 92501, United States

Location

California Pacific Medical Research Institute

San Francisco, California, 94115, United States

Location

University of California - SF

San Francisco, California, 94115, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 21113, United States

Location

Advanced Medical Specialties

Miami, Florida, 33176, United States

Location

Florida Cancer Institute

New Port Richey, Florida, 34655, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Cancer Centers of Florida, PA

Orlando, Florida, 32806, United States

Location

Hematology/Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Suburban Hematology-Oncology

Lawrenceville, Georgia, 30045, United States

Location

Cancer Care Specialists of Central Illinois

Decatur, Illinois, 62526, United States

Location

Comprehensive Cancer Program

Harvey, Illinois, 60426, United States

Location

Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois, 60714, United States

Location

OSF Center for Cancer Care

Rockford, Illinois, 61108-2472, United States

Location

Loyola Cancer Care and Research Center

Winfield, Illinois, 60190, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Siouxland Hematology-Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Kansas City Cancer care, Southwest

Overland Park, Kansas, 66210, United States

Location

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Cancer Center of Texas

Wichita, Kansas, 67214, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Western Kentucky Hematology & Oncology

Paducah, Kentucky, 42003, United States

Location

Harry & Jeannette Weinberg Cancer Institute

Baltimore, Maryland, 21237, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89074, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Advanced Oncology Associates

Armonk, New York, 10504, United States

Location

Arena Oncology Associates, P.C.

Lake Success, New York, 11042, United States

Location

NY Oncology/Hematology - Latham

Latham, New York, 12110, United States

Location

Winthrop Hematology/Oncology

Mineola, New York, 11501, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cancer Center of North Carolina

Raleigh, North Carolina, 27606, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Hematology Oncology Consultants, Inc.

Columbus, Ohio, 43235, United States

Location

Signal Point Hematology/Oncology, Inc.

Middletown, Ohio, 45042, United States

Location

Kaiser Permanante, Northwest Region

Portland, Oregon, 97227, United States

Location

St. Luke's Hospital & Healtth Network

Bethlehem, Pennsylvania, 18015, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Texas Cancer center - Abilene

Abilene, Texas, 79606, United States

Location

Texas Oncology - Arlington South

Arlington, Texas, 76014-2084, United States

Location

Mamie McFadden Ward Cancer Ctr, Texas Oncology

Beaumont, Texas, 77702-1449, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology at Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Methodist Charlton Cancer Center

Dallas, Texas, 75237, United States

Location

UT Southwester Med Ctr at Dallas

Dallas, Texas, 75390, United States

Location

Texas Cancer Center - Denton

Denton, Texas, 76210, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

Texas Oncology - Allison Cancer Center

Midland, Texas, 79701, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Blood and Cancer Center of East Texas

Tyler, Texas, 75791, United States

Location

Texas Oncology Cancer Care Center & Research Center

Waco, Texas, 76712, United States

Location

Puget Sound Cancer Centers

Edmonds, Washington, 98026, United States

Location

Fred Hutchinson Cancer Reseach Center

Seattle, Washington, 98109, United States

Location

Puget Sound Cancer Center

Seattle, Washington, 98133, United States

Location

Evergreen Hematology and Oncology

Spokane, Washington, 99218, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

Novartis Investigative Site

Antwerp, Belgium

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Novartis Investigative Site

Arlon, Belgium

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Novartis Investigative Site

Brussels, Belgium

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Novartis Investigative Site

Genk, Belgium

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Novartis Investigative Site

Ghent, Belgium

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Novartis Investigative Site

Leuven, Belgium

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Novartis Investigative Site

Liège, Belgium

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Novartis Investigative Site

Namur, Belgium

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Novartis Investigative Site

Edmonton, Canada

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Novartis Investigative Site

Greenfield Park, Canada

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Novartis Investigative Site

Laval, Canada

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Novartis Investigative Site

Montreal, Canada

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Novartis Investigative Site

Toronto, Canada

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Novartis Investigative Site

Trois-Rivières, Canada

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Novartis Investigative Site

Vancouver, Canada

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Novartis Investigative Site

Weston, Canada

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Novartis Investigative Site

Winnepeg, Canada

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Novartis Investigative Site

Avignon, France

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Novartis Investigative Site

Brest, France

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Novartis Investigative Site

Caen, France

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Novartis Investigative Site

La Chaussée-Saint-Victor, France

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Novartis Investigative Site

Le Mans, France

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Novartis Investigative Site

Lille, France

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Novartis Investigative Site

Nîmes, France

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Novartis Investigative Site

Paris, France

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Novartis Investigative Site

Perpignan, France

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Novartis Investigative Site

Rennes, France

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Novartis Investigative Site

Vandœuvre-lès-Nancy, France

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Novartis Investigative site

Bamberg, Germany

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Novartis Investigative Site

Berlin, Germany

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Novartis Investigative Site

Cologne, Germany

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Novartis Investigative Site

Coswig, Germany

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Novartis Investigative Site

Eschweiler, Germany

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Novartis Investigative Site

Essen, Germany

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Novartis Investigative Site

Freiburg im Breisgau, Germany

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Novartis Investigative Site

Großhansdorf, Germany

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Novartis Investigative Site

Güstrow, Germany

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Novartis Investigative Site

Halle, Germany

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Novartis Investigative Site

Hamburg, Germany

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Novartis Investigative Site

Hanover, Germany

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Novartis Investigative Site

Hemer, Germany

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Novartis Investigative Site

Leipzig, Germany

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Novartis Investigative Site

Magdeburg, Germany

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Novartis Investigative Site

München, Germany

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Novartis Investigative Site

Münster, Germany

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Novartis Investigative Site

Oldenburg, Germany

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Novartis Investigative Site

Ulm, Germany

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Novartis Investigative site

Deszk, Hungary

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Novartis Investigative Site

Gyula, Hungary

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Novartis Investigative Site

Székesfehérvár, Hungary

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Novartis Investigative Site

Törökbálint, Hungary

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Novartis Investigative Site

Zalaegerszeg-Pozva, Hungary

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Novartis Investigative Site

Ancona, Italy

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Novartis Investigative Site

Aviano, Italy

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Novartis Investigative Site

Bologna, Italy

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Novartis Investigative Site

Cosenza, Italy

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Novartis Investigative Site

Cremona, Italy

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Novartis Investigative Site

Milan, Italy

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Novartis Investigative Site

Mirano, Italy

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Novartis Investigative Site

Monza, Italy

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Novartis Investigative Site

Napoli, Italy

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Novartis Investigative Site

Palermo, Italy

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Novartis Investigative Site

Reggio Emilia, Italy

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Novartis Investigative Site

Sassari, Italy

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Novartis InvestigativeSite

Udine, Italy

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Novartis Investigative Site

Bialystok, Poland

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Novartis Investigative Site

Lonza, Poland

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Novartis Investigative Site

Szczecin, Poland

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Novartis Investigative Site

Warsaw, Poland

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Novartis Investigative Site

Mataró, Spain

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Novartis investigative Site

Sabadell, Spain

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Novartis Investigative Site

Santander, Spain

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Novartis Investigative Site

Geneva, Switzerland

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Novartis Investigative site

Sankt Gallen, Switzerland

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Related Links

• Results for CASA404A2302 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vadimezan; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Last Updated: December 24, 2020

Record last verified: 2012-05

Locations

DE (19); HU (5); FR (11); CH (2); US (88); BE (8); CA (9); PL (4); IT (13); ES (3)