INTERNATIONAL, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF GEMCITABINE/CISPLATIN PLUS PF-3512676 VERSUS GEMCITABINE/CISPLATIN ALONE AS FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-004557-10-IT
• Date of registration: 04/12/2006
• Prospective Registration: No
• Primary sponsor: PFIZER
• Public title: INTERNATIONAL, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF GEMCITABINE/CISPLATIN PLUS PF-3512676 VERSUS GEMCITABINE/CISPLATIN ALONE AS FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER
• Scientific title: INTERNATIONAL, RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF GEMCITABINE/CISPLATIN PLUS PF-3512676 VERSUS GEMCITABINE/CISPLATIN ALONE AS FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER
• Date of first enrolment: 12/04/2006
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004557-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Czech Republic, Germany, Hungary, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer NSCLC Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification. 2. Advanced NSCLC with documented AJCC Stage IIIB with pleural effusion or Stage IV disease. 3. Measurable disease defined by at least one lesion that can be accurately measured in at least one dimension as 20 mm with conventional techniques or 10 mm with spiral CT scan within 28 days prior to the planned start of study treatment RECIST criteria . Note Prior radiation to the only site of measurable disease will deem the patient ineligible unless progression is documented at the site after completion of radiation. 4. No prior systemic treatment for NSCLC with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs. 5. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to enrollment and all acute toxicities have resolved to baseline or to CTC Grade 1 NCI CTCAE v3.0 6. Males or females aged 18 years 7. ECOG performance status PS 0 or 1 8. Adequate organ function as determine by the following criteria Absolute neutrophil count ANC 1.5 x 10 9 /L. Platelet count 100 x 10 9 /L Calculated creatinine clearance 50 mL/min or measured creatinine clearance 60 mL/min. AST SGOT and ALT SGPT / 3 x ULN AST and ALT / 5 x ULN is acceptable, in the presence of liver metastases Total bilirubin / 1.5 x ULN 9. Female patients or their partners must be surgically sterile or be postmenopausal, or mustagree to use effective contraception while receiving study treatment and for at least 3 months thereafter. All female patients with reproductive potential must have a negative pregnancy test serum/urine within the 72 hours prior to starting treatment. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. 10. Written, voluntary informed consent provided
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. Any histological/cytological evidence of small cell or carcinoid lung cancer. 2. Known central nervous system CNS metastasis. CNS imaging is not required at baseline for patients who have no symptoms suggestive of CNS metastases 3. Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes Pre-existing autoimmune or antibody-mediated diseases including but not limited to systemic lupus, erythematosis, rheumatoid arthritis, multiple sclerosis, Sjogren s syndrome, autoimmune thrombocytopenia or glomerulonephritis. History of allogeneic transplant. Untreated and/or uncontrolled superior vena cava syndrome. Untreated and/or uncontrolled hypercalcemia. Requirement for chronic treatment with therapeutic doses of systemic corticosteroids. Use of antihistamines, steroid inhalers, or oral physiologic replacement doses of corticosteroids is permitted. Physiological replacement doses will be defined as / 37.5 mg/day of cortisone, / 7.5 mg/day of prednisolone or / 1.0 mg/day of dexamethasone. Patients on other replacement regimens must be discussed with the sponsor. Uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 6 months, or serious uncontrolled cardiac arrhythmia. Active bacterial, fungal or viral infection including hepatitis B HBV , hepatitis C HBC and human immunodeficiency virus HIV . Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection. Pre-existing peripheral neuropathy CTC Grade 2. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol. 4. History of any active malignancy other than NSCLC during the last 3 years except non-melanoma skin cancer, in situ cervical cancer, or cured, early prostate cancer in a patient with PSA level ULN. 5. Known or suspected hypersensitivity to any of the study drugs gemcitabine, cisplatin or PF-3512676 , study drug classes pyrimidine analogs, platinum, oligodeoxynucleotide ODN or excipients in the formulation of study drugs. 6. Female patients who are pregnant or nursing. 7. Inability or lack of willingness to comply with scheduled visits, therapy plans or laboratory tests. 8. Current enrollment in another therapeutic clinical trial. 9. Use of any investigational agent in the past 4 weeks.


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

Health Condition(s) or Problem(s) studied

First line treatment of chemotherapy-naive patients with locally advanced Stage IIIB with pleural effusion or metastatic Stage IV Non-Small Cell Lung Cancer NSCLC
MedDRA version: 6.1 Level: PT Classification code 10025070

Intervention(s)

Product Name: PF-3512676
Product Code: PF-3512676
Pharmaceutical Form: Solution for injection
Current Sponsor code: PF-3512676
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-

Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1250-

Primary Outcome(s)

Primary end point(s): Overall survival OS defined as the time from randomization to the date of death due to any cause.

Secondary Objective: - To compare additional measures of efficacy, safety and health-related quality of life and disease/treatment-related symptoms in patients randomized to gemcitabine/cisplatin PF-3512676 versus patients randomized to gemcitabine/cisplatin alone. To evaluate the effect of PF-3512676 on the pharmacokinetics of gemcitabine and cisplatin To evaluate the pharmacokinetics of PF-3512676 when administered in combination with gemcitabine and cisplatin.

Main Objective: To compare overall survival OS in patients randomized to gemcitabine/cisplatin PF-3512676 Investigational Treatment Arm versus that in patients randomized to gemcitabine/cisplatin alone Control Treatment Arm .

Secondary ID(s)

A8501002

2005-004557-10-GB