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An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With NSCLC

Phase 1
20 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With NSCLC

Inclusion Criteria

Inclusion criteria:

1. Histologically or cytologically confirmed non-small cell carcinoma of the lung.

2. Newly diagnosed Stage IIIb disease or Stage IV disease

3. No prior treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Note:
Prior neoadjuvant or adjuvant chemotherapy within 6 months is allowed.)

4. Age ≥ 20 years old

5. WHO Performance status of 0-1

6. Lab values within the range as defined below within 2 weeks of study registration
(Note: without the use of growth factors or blood transfusions):

- Absolute neutrophil count (ANC) > 2.0 x 109/L

- Platelets ≥ 100 x109/L

- Hemoglobin ≥ 9.5 g/dL

- Serum creatinine ≤ 1.5 x ULN or 1.5 mg/dL

- Serum bilirubin ≤ 1.5 x ULN

- Aspartate transaminase (AST) and alanine transaminase (ALT)

≤ 2.5 x ULN

- PT-INR ≤ 1.5 x ULN

- Potassium ≥ LLN or correctable with supplements.

- Total calcium (corrected for serum albumin) ≥ LLN or correctable with

- Magnesium ≥ LLN or correctable with supplements.

- Females of child-bearing potential must have negative pregnancy test (serum)

7. Life expectancy ≥ 12 weeks

8. Written informed consent obtained according to local guidelines

Exclusion criteria:

1. Patients having symptomatic CNS metastases and requiring treatment

2. Patients with second primary cancer, with the exception of non-melanoma skin cancer
or cervical cancer in situ.

3. Radiotherapy ≤ 4 weeks prior to registration (In case of palliative radiotherapy 2
weeks prior to registration

4. Major surgery ≤ 4 weeks prior to registration (major surgery is defined by the use of
general anesthesia). Minor surgery ≤ 2 weeks prior to registration. Insertion of a
vascular access device is allowed. Patients must have recovered from all
surgery-related complications.

5. Concurrent use of other investigational agents and patients who have received
investigational agents ≤ 4 weeks prior to registration

6. Prior exposure to VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF
receptor agents, anti-EGFR agents

7. Patients with pleural effusion to be drained (Patients who have recurrence of pleural
effusion and/or it takes 2 weeks before registration after drainage are allowed)

8. Patients with recent hemoptysis associated with NSCLC (>1 teaspoon in a single
episode within 4 weeks)

9. Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs
formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of
these drugs.

10. Peripheral sensory neuropathy with functional impairment (CTC Grade 2 neuropathy,
regardless of causality)

11. ≥ CTC Grade 2 cardiac arrhythmias (i.e. symptomatic, but may not require

12. Pregnant or breast feeding females

13. Patients who take medicine that are known to prolong the QT interval

14. 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.)

15. Patients with any one of the following

- Patients with Long QT Syndrome

- Patients with a Baseline 12-lead ECG QTc of > 450 msec in males or > 470 msec in

- Congestive heart failure(NY Heart Association class III or IV)

- Patients with a myocardial infarction within 12 months of study entry

- Unstable or poorly controlled angina pectoris

- History of poorly controlled hypertension with anti-hypertensive regimen

- History of a sustained ventricular tachycardia

- Any history of ventricular fibrillation or Torsades de Pointes

- Right bundle branch block and left anterior hemiblock (bifasicular block)

- Bradycardia defined as heart rate < 50 beat per minutes

16. 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).

17. Patients known to be HBV or HCV positive

18. Significant neurological or psychiatric disorder which could compromise participation
in the study

19. Patient unwilling or unable to comply with the protocol

20. Patients who are not adequate to enter the study decided by the investigator from the
medical point of view.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety profile and tolerability of ASA404 when administered in combination with paclitaxel and carboplatin in Japanese patients with non small cell lung cancer

Outcome Time Frame:

First cycle

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Vascular disrupting agent
  • Non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms