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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Toxicity Free Survival

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Lucio Crinò, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Ospedaliera di Perugia

Authority:

Italy: Ethics Committee

Study ID:

2010-022021-15

NCT ID:

NCT01379976

Start Date:

April 2011

Completion Date:

October 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • lung
  • cancer
  • non small cell lung cancer
  • Advanced or metastatic non small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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