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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2008-002309-38-IT
Date of registration:	17/12/2008
Prospective Registration:	Yes
Primary sponsor:	NOVARTIS FARMA
Public title:	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) - ATTRACT-2
Scientific title:	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) - ATTRACT-2
Date of first enrolment:	13/02/2009
Target sample size:	900
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002309-38
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Belgium	Germany	Hungary	Italy	Netherlands	Poland	Spain	United Kingdom

Contacts

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Key inclusion & exclusion criteria

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. Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1) 6. 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 (≤ 120 micro mol/L) Serum bilirubin ≤ 1.5 x ULN (≤ 25 micro mol/L) Alkaline phosphatase ≤ 2.5 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) 7. Life expectancy ≥ 12 weeks 8. Written informed consent obtained according to local guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (major surgery is defined by the use of general anesthesia). Endoscopic examinations with diagnostic intent are not considered major surgery. Minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is allowed. Insertion of a vascular access device is not considered major or minor surgery. Patients must have recovered from all surgery-related complications. 5. Treatment with first-line chemotherapy regimen ≤ 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 first-line setting 8. Prior treatment with VDAs or tumor - VDAs for NSCLC in the first-line setting 9. Pleural effusion that causes ≥ 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 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 or with implanted cardiac pacemaker 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 13. Concomitant use of drugs with a risk of causing Torsades de Pointes (See Table 6-3 and Appendix 2) 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.)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with locally advanced or metastatic Stage IIIb/IV NSCLC, of all histologies, who have progressed while on or following a first-line chemotherapy regimen and are eligible for second-line chemotherapy
MedDRA version: 9.1 Level: LLT Classification code 10066490 Term: Progression of non small cell lung cancer

Intervention(s)

Product Code: ASA404
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 29095-08-5
Current Sponsor code: ASA404
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: TAXOTERE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Trade Name: TAXOTERE
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: To compare overall survival between the ASA404 plus docetaxel group and the placebo plus docetaxel group

Secondary Objective: To compare Progression-Free Survival (PFS) and the Overall Response Rate (ORR) per RECIST assessed by the investigators between patients receiving ASA404 or placebo in combination with docetaxel

Primary end point(s): overall survival

Secondary Outcome(s)

Secondary ID(s)

CASA404A2302

2008-002309-38-ES

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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