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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT n° 2007-004521-22 |
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The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. |
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| B | Placebo Comparator | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1.Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474, Vandetanib | Drug | 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Oct 2008- dec 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Oct 2008- dec 2011 | |
| Overall Objective Response | Oct 2008- dec 2011 | |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Meldola | (fc) | Italy | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18165633 | Background | Gridelli C. Treatment of advanced non small-cell lung cancer in the elderly: from best supportive care to the combination of platin-based chemotherapy and targeted therapies. J Clin Oncol. 2008 Jan 1;26(1):13-5. doi: 10.1200/JCO.2007.14.1820. No abstract available. |
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A total of 124 patients have been enrolled in a period of 19 months in 17 actively recruiting Oncologic Medical Department in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | ZD6474 (Vandetanib),Gemcitabine | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo to Match ZD6474, Vandetanib | Drug | 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
|
|
| Gemcitabine | Drug | administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
|
|
| Oct 2008- dec 2011 |
| The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine | The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes | Oct 2008- Dec 2011 |
| Avellino |
| AV |
| Italy |
| Research Site | Bari | BA | Italy |
| Research Site | Treviglio | BG | Italy |
| Research Site | Bologna | BO | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Taormina | ME | Italy |
| Research Site | Milan | MI | Italy |
| Research Site | Perugia | PG | Italy |
| Research Site | Ravenna | RA | Italy |
| Research Site | Roma | Roma | Italy |
| Research Site | Trento | TN | Italy |
| Research Site | Orbassano | TO | Italy |
| Research Site | Udine | UD | Italy |
| Research Site | Padova | Italy |
| FG001 | Placebo to Match ZD6474 (Vandetanib),Gemcitabine | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ZD6474 (Vandetanib),Gemcitabine | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. |
| BG001 | Placebo to Match ZD6474 (Vandetanib),Gemcitabine | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Posted | Median | 95% Confidence Interval | days | Oct 2008- dec 2011 |
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| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | days | Oct 2008- dec 2011 |
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| Secondary | Overall Objective Response | Posted | Number | Participants | Oct 2008- dec 2011 |
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| Secondary | Duration of Response | Posted | Median | 95% Confidence Interval | days | Oct 2008- dec 2011 |
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| Secondary | The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine | The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes | Posted | Number | Adverse Events | Oct 2008- Dec 2011 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ZD6474 (Gemcitabine), Vandetanib | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with vandetanib alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued. | 26 | 61 | 59 | 61 | ||
| EG001 | Placebo to Match ZD6474 (Gemcitabine), Vandetanib | Gemcitabine administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1. . Patients will receive gemcitabine for up to a maximum of 6 cycles, after which period patients should continue on daily oral dosing with placebo alone until progression. Once a patient has met the study criteria for disease progression on vandetanib/gemcitabine or placebo/gemcitabine, randomised treatment must be permanently discontinued | 25 | 63 | 62 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pulmunary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Pulmunary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| acute pulmunary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| chronic obstructive pulmunary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Pleuropericarditis | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Depressed Level Of Consciuosness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Cerebral Ischemia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Uraniry Retention | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Skin Toxicity | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Eye Disorder | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Weight Decrease | Investigations | MedDRA 12.0 | Non-systematic Assessment |
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| Muscoloskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Ear Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Oesophageal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Infarction | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Vena Cava Thrombosis | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Dispnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| PLT count decrease | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hypokaliemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pulmunary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Neutrphil Count Decreased | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Aspartate Aminotransferase Inctìreased | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010995 | Pleural Diseases |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Male |
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| Participants |
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| Participants |
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| Participants |
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