Estudio Fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de ASA404 en combinación con docetaxel, como tratamiento de segunda línea para pacientes con cáncer de pulmón de células no pequeñas (NSCLC) localmente avanzado o metastásico (estadio IIIb/IV) - ATTRACT-2

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002309-38-ES
• Date of registration: 30/10/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A.
• Public title: Estudio Fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de ASA404 en combinación con docetaxel, como tratamiento de segunda línea para pacientes con cáncer de pulmón de células no pequeñas (NSCLC) localmente avanzado o metastásico (estadio IIIb/IV) - ATTRACT-2
• Scientific title: Estudio Fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de ASA404 en combinación con docetaxel, como tratamiento de segunda línea para pacientes con cáncer de pulmón de células no pequeñas (NSCLC) localmente avanzado o metastásico (estadio IIIb/IV) - ATTRACT-2
• Date of first enrolment: 22/12/2008
• 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

Countries of recruitment

Belgium, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically confirmed non-small cell carcinoma of the lung of all histologies.
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
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
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 firstline 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 antihypertensive 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
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
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.
18. Concurrent severe and/or uncontrolled medical disease
19. Significant neurologic or psychiatric disorder which could compromise participation in the study
20. Patient unwilling or unable to comply with the protocol


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

Health Condition(s) or Problem(s) studied

Pacientes con cancer de pulmón de célula no pequeña, estadio IIIb/IV que han progresado durante o tras recibir una primera linea de quimioterapia
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
Other descriptive name: 5,6-Dimethylxanthenone-4-acetic acid
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Trade Name: TAXOTERE 20 mg concentrado y disolvente para solución para perfusión
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Other descriptive name: DOCETAXEL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: Comparar la supervivencia global entre el grupo de pacientes que reciben ASA404 y docetaxel y el grupo de pacientes que recibe placebo y docetaxel

Primary end point(s): The primary efficacy endpoint will be overall survival

Secondary Objective: Comparan la supervivencia libre de progresión y la tasa de respuesta global según los criterios RECIST evaluados por el investigador entre pacientes que reciban ASA404 o placebo en combinación con docetaxel.

Secondary ID(s)

CASA404A2302