Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Assess the Efficacy and Safety of Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer
Inclusion criteria:
- Male or female >= 18
- No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is
permitted if completed ≥ 6 months before study inclusion.
- ECOG performance status 0-1
- Adequate organ functions defined as follows:
- Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL
- Bilirubin level either normal or < 1.5 x ULN
- ASAT and ALAT <= 2.5 x ULN (<= 5 x ULN if liver metastasis are present)
- Serum creatinine <1.5 x ULN
- Written informed consent given before the randomization, according to International
Conference on Harmonization/Good Clinical Practice (ICH/GCP)
Exclusion criteria:
- Symptomatic brain metastases
- Any investigational agent(s) within 4 weeks prior to study entry
- Clinically relevant coronary artery disease or a history of a myocardial infarction
within the last 12 months
- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- Patients with known allergy to any other components of the study drugs
- History or presence of other disease, metabolic dysfunction, physical examination
finding, or clinical laboratory finding giving reasonable suspicion of a disease or
condition that contraindicates use of an investigational drug or patient at high risk
from treatment complication
- Known drug abuse/ alcohol abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent
- Clinically relevant peripheral neuropathy
- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of
the cervix (Patients with a previous malignancy but without evidence of disease for 5
years will be allowed to enter the trial)
- Pregnancy or breast feeding. Women of childbearing potential and their parents must be
willing to practice acceptable methods of birth control to prevent pregnancy
- Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Toxicity Free Survival
The primary efficacy endpoint is toxicity-free survival, defined as the time from randomisation up to the occurrence of related to treatment grade 2-3-4 NCI-CTCAE neurotoxicity, progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not experienced related to treatment grade 2-3-4 toxicity, and not progressed or died while on study will be censored at their last assessment date.
participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months
Yes
Lucio Crinò, MD
Principal Investigator
Azienda Ospedaliera di Perugia
Italy: Ethics Committee
2010-022021-15
NCT01379976
April 2011
October 2014
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