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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)


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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)


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 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.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CASA404A2302

NCT ID:

NCT00738387

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Tumor vascular disrupting agent
  • VDA
  • ASA404
  • non-small cell lung cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Scripps ClinicLa Jolla, California  92037
Florida Hospital Cancer InstituteOrlando, Florida  32804
MetroHealth Medical CenterCleveland, Ohio  44109
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Rocky Mountain Cancer CenterDenver, Colorado  80218
Ocala Oncology CenterOcala, Florida  34474
Hollings Cancer CenterCharleston, South Carolina  29403
Missouri Cancer AssociatesColumbia, Missouri  65201
Stanford Cancer CenterStanford, California  94305-5824
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Temple University HospitalPhiladelphia, Pennsylvania  19140
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Highlands Oncology GroupSpringdale, Arkansas  72764
Tyler Cancer CenterTyler, Texas  75702
Duke University Medical CenterDurham, North Carolina  27710
Northwest Cancer SpecialistsVancouver, Washington  98664
SUNY Upstate Medical UniversitySyracuse, New York  13210
Advanced Oncology AssociatesArmonk, New York  10504
UCLALos Angeles, California  90095
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
North Valley Hematology/Oncology Medical GroupNorthridge, California  91328
Bay Area Cancer Research GroupConcord, California  94520
Georgetown University HospitalWashington, District of Columbia  20007
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texas Cancer Center at Medical CityDallas, Texas  75230
Suburban Hematology-OncologySnellville, Georgia  30078-6782
Hematology/Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
Nevada Cancer InstituteLas Vegas, Nevada  89135
Longview Cancer CenterLongview, Texas  75601
Multicare Health SystemTacoma, Washington  98415
University of California Irvine Medical CenterOrange, California  92668
Puget Sound Cancer CentersEdmonds, Washington  98026
OSF Center for Cancer CareRockford, Illinois  61108
Blood and Cancer Center of East TexasTyler, Texas  75701
Texas Cancer Center - AbileneAbilene, Texas  79606
Texas Cancer Center - DentonDenton, Texas  76210
Paris Regional Cancer CenterParis, Texas  75460
Texas Cancer Center - ShermanSherman, Texas  75090-0504
New Mexico Cancer CenterAlbuquerque, New Mexico  87109
Signal Point Hematology/Oncology, Inc.Middletown, Ohio  45042
Sarah Cannon Research InstituteNashville, Tennessee  37203
Puget Sound Cancer CenterEdmonds, Washington  98026
Compassionate Cancer Care Medical GroupCorona, California  92882
Cancer Care Specialists of Central IllinoisDecatur, Illinois  62256
Horizon Oncology CenterLafayette, Indiana  47905
Providence Medical GroupTerre Haute, Indiana  47802
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Advanced Medical SpecialtiesMiami, Florida  33176
Cancer Centers of Florida, PAOrlando, Florida  32822
Winthrop Hematology/OncologyMineola, New York  11501
Cancer Center of North CarolinaRaleigh, North Carolina  27614
St. Jude Heritage HealthcareFullerton, California  92835
Arena Oncology Associates, P.C.Lake Success, New York  11042
Evergreen Hematology And OncologySpokane, Washington  99218
Harry & Jeannette Weinberg Cancer InstituteBaltimore, Maryland  21237
Loma Linda Oncology Medical Group, Inc.Redlands, California  92374
California Pacific Medical Research InstituteSan Francisco, California  94115
Texas Oncology at Presbyterian HospitalDallas, Texas  75231
Central Hematology Oncology Medical GroupAlhambra, California  91801
Oncology Specialist, P.c.Huntsville, Alabama  35805
Arizona OncologyTucson, Arizona  85704
Beaver Medical Group, L.P.Highland, California  92346
University of Southern CalifornaLos Angeles, California  90033-0800
Ventura County Hematology/Oncology SpecialistsOxnard, California  93030
Palo Alto Medical Foundation - Camino Div.Palo Alto, California  94301
University of California - SFSan Francisco, California  94115
Comprehensive Cancer ProgramHarvey, Illinois  60426
Loyola Cancer Care and Research CenterWinfield, Illinois  60190
Kansas City Cancer care, SouthwestOverland Park, Kansas  66210
Cancer Center of TexasWichita, Kansas  67214
Western Kentucky Hematology & OncologyPaducah, Kentucky  42003
NY Oncology/Hematology - LathamLatham, New York  12110
Kaiser Permanante, Northwest RegionPortland, Oregon  97227
St. Luke's Hospital & Healtth NetworkBethlehem, Pennsylvania  18015
Texas Oncology - Arlington SouthArlington, Texas  76014-2084
Mamie McFadden Ward Cancer Ctr, Texas OncologyBeaumont, Texas  77702-1449
UT Southwester Med Ctr at DallasDallas, Texas  75390
Methodist Charlton Cancer CenterDallas, Texas  75237
Texas Oncology - Allison Cancer CenterMidland, Texas  79701
Texas Oncology Cancer Care Center & Research CenterWaco, Texas  76712
Fred Hutchinson Cancer Reseach CenterSeattle, Washington  98109