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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
Not Enrolling
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

- 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

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

- 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

- [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

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

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:


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:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

Related Keywords:

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



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