Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00662597




Registration number
NCT00662597
Ethics application status
Date submitted
17/04/2008
Date registered
21/04/2008
Date last updated
24/12/2020

Titles & IDs
Public title
ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer
Scientific title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
CASA404A2301
Universal Trial Number (UTN)
Trial acronym
ATRACT-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: ASA404 -

Placebo comparator: ASA40 Placebo -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival rate
Timepoint [1] 0 0
Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.
Secondary outcome [1] 0 0
Overall survival of patients with squamous and non-squamous NSCLC
Timepoint [1] 0 0
Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.

Eligibility
Key inclusion criteria
1. Histologically confirmed non-small cell carcinoma of the lung. (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. Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
3. No prior systemic antineoplastic treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Prior neoadjuvant or adjuvant chemotherapy for earlier stage I/II NSCLC is allowed if 12 months or more prior to Baseline visit.)
4. Age = 18 years old
5. WHO Performance Status of 0-1
6. Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
7. Lab 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 (= 120 micro mol/L)
* Serum bilirubin = 1.5 x ULN (= 25 micro mol/L)
* 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 IULN (Sections 6.9.1 and 7.3.4.2)
* Electrolyte values (potassium, calcium, magnesium) within > 1 x LLN and < 1 x ULN. Patients with corrected electrolyte values are eligible. See Sections 6.8.1 and 7.3.4.3.
* Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing).
8. Life expectancy = 12 weeks
9. Written informed consent obtained according to local guidelines
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 a history of another primary malignancy = 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
3. Radiotherapy = 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
4. Major surgery = 4 weeks prior to randomization or minor surgery = 2 weeks prior to randomization.(Major surgery is defined by the use of general anesthesia however, endoscopic examinations with diagnostic intent are not considered major surgery. Insertion of a vascular access device is exempt from this exclusion criteria. 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 randomization
6. Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents [bevacizumab, cetuximab, etc.])
7. Pleural effusion that causes = CTC grade 2 dyspnea
8. Patients with systolic BP > 160 mm Hg and/or diastolic BP >90 mm Hg
9. Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
10. Patients with any one of the following:

* Patients with long QT syndrome
* Patients with a Baseline 12-lead ECG QTc of > 450 msec per central evaluation
* 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, including Prinzmetal variant angina pectoris
* History of labile hypertension or poor compliance 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 beats per minute
11. Concomitant use of drugs with a risk of causing Torsades de Pointes (See Table 6-3)
12. 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.
13. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
14. 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)
15. 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 paclitaxel 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/)
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. Significant neurologic or psychiatric disorder which could compromise participation in the study Patient unwilling or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
1285
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - South Brisbane
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment outside Australia
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Alabama
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London
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Moncton
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Rimouski
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Leipzig
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Israel
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Israel
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Israel
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Israel
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Zrifin
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Milano
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Parma
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Italy
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Perugia
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Roma
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Japan
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Akashi
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Fukuoka
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Habikino
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Hiroshima
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Kashiwa
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Kobe-city
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Koto
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Kumamoto
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Kurashiki
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Matsuyama
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Nagoya
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Niigata
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Japan
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Okayama
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Osaka Sayama
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Osaka
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Sapporo
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Ube
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Korea, Republic of
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Suwon
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Amsterdam
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Breda
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Hertogenbosch
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Zwolle
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Auckland
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Christchurch
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Hamilton
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Wellington
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Poland
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Lublin
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Barcelona
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Zaragoza
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Sweden
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Umea
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Taiwan
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Kaoshiung
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Lin-Ko
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Taichung
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Taipei
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Istanbul
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Izmir
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Aberdeen
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Cambridge
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Leicester
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London
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Manchester
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00662597