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This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vandetanib | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vandetanib | Drug | Tablet, oral, daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Rate at 3 Months | Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression. | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. |
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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 | Cheongju-si | Republic of Korea | South Korea | |||
| Research Site |
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First patient enrolled: 13 October 2008 Last patient enrolled: 7 December 2009 This study was conducted at Division of oncology, Department of Medicine of general hospitals in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vandetanib | Vandetanib 300 mg, orally, once daily |
| FG001 | Placebo | Matching Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Placebo |
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| Overall Survival (OS) |
Overall survival (OS) defined as the median time from randomization to death from any cause. |
| Every 12 weeks unless the patient withdraws consent |
| Disease of Response (DOR) | Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. |
| Objective Response Rate (ORR) | Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response. | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. |
| Gyeonggi-do |
| Republic of Korea |
| South Korea |
| Research Site | Gyeongsangnam-Do | Republic of Korea | South Korea |
| Research Site | Incheon | Republic of Korea | South Korea |
| Research Site | Seoul | Republic of Korea | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vandetanib | Vandetanib 300 mg, orally, once daily |
| BG001 | Placebo | Matching Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Smoking history | Number | Participants |
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| Overall response at screening | completion of 4 cycles of chemotherapy of gemcitabine (1,000mg/m^2/day or 1,250mg/m^2/day on day 1 and 8) and cisplatin (70mg/m^2/day~80mg/m^2/day on day 1) every 3 weeks and have shown responses (CR, PR) or stable disease (SD) by RECIST 1.0. | Number | Participants |
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| WHO Performance status | WHO PS (0: Fully active, able to carry out all usual activities without restrictions and without the aid of analgesia. 1: Restricted in strenuous activity, but ambulatory and able to carry out light work or pursue a sedentary occupation. This group also contains subjects who are fully active, as in grade 0, but only with the aid of analgesics.) | Number | Participants |
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| Histology | Histology | Number | Participants |
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| Classification of lung tumor stage | Classification (Stage IIIb: Any T - N3 - M0 or T4 - Any N - M0, Stage IV: Any T - Any N - M1) | Number | 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 (PFS) Rate at 3 Months | Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients. | The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set. | Posted | Number | Participants | 12 weeks |
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| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression. | Posted | Median | 95% Confidence Interval | months | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. |
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| Secondary | Overall Survival (OS) | Overall survival (OS) defined as the median time from randomization to death from any cause. | Posted | Median | 95% Confidence Interval | months | Every 12 weeks unless the patient withdraws consent |
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| Secondary | Disease of Response (DOR) | Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response | Posted | Number | Participants | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. |
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| Secondary | Objective Response Rate (ORR) | Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response. | Posted | Number | Participants | Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression. |
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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 | Vandetanib | Vandetanib 300 mg, orally, once daily | 18 | 75 | 72 | 75 | ||
| EG001 | Placebo | Matching Placebo | 4 | 42 | 37 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest discomfort | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Ileal perforation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Anxiety | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (10.0) | 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 |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
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| Male |
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| Non-smoker |
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| Stable Disease (SD) |
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| 1 |
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| Squamous cell carcinoma |
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| Other |
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| Stage IV |
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