Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT Number 2007-003633-16 |
Not provided
Not provided
Not provided
Recruitment stopped according to early stopping rule (by protocol)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Vinorelbine |
|
| 2 | Experimental | Vandetanib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vinorelbine | Drug |
|
| |
| Vandetanib |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Control. | Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD. | Assessed at 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Objective Response. | Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Essen | Germany | ||||
| Research Site |
Not provided
First subject enrolled: 17 December 2007, Last subject last visit: 22 July 2009.
The study was conducted at 2 centres in Switzerland and 4 centres in Germany.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vandetanib | Vandetanib 300 mg/day oral |
| FG001 | Vinorelbine | Vinorelbine 30 mg/m2 iv, administrated weekly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vandetanib | Vandetanib 300 mg/day oral |
| BG001 | Vinorelbine | Vinorelbine 30 mg/m2 iv, administrated weekly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Disease Control. | Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD. | Only patients in the evaluable for efficacy population were included.It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles(unless progressive disease occurred at cycle 1)and who had at least one post-treatment tumour assessment. | Posted | Number | Participants | Assessed at 2 months. |
|
Not provided
The enrolled and randomised population was Vandetanib 14 & Vinorelbine 11. However, demographic and baseline characteristics were analyzed for evaluable patients = safety population (Vandetanib 13 & Vinorelbine 10)
Not provided
| 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/day oral |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous stasis | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
Early termination leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
Not provided
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| C452423 | vandetanib |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
once daily oral dose |
|
|
| Assessed at 2 months. |
| Progression-free Survival (PFS) | Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. | Assessed from baseline to 12 months. |
| Overall Survival (OS) | Assessed from baseline to 12 months. |
| Halle-Dolau |
| Germany |
| Research Site | Hamburg | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Chur | Switzerland |
| Research Site | Zurich | Switzerland |
| Physician Decision |
|
| Death |
|
| Lost to Follow-up |
|
| Progressive disease |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Vandetanib | Vandetanib 300 mg/day oral |
| OG001 | Vinorelbine | Vinorelbine 30 mg/m2 iv, administrated weekly |
|
|
| Secondary | Number of Participants With Objective Response. | Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. | Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment. | Posted | Number | Participants | Assessed at 2 months. |
|
|
|
| Secondary | Progression-free Survival (PFS) | Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. | Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment. | Posted | Median | 95% Confidence Interval | Months | Assessed from baseline to 12 months. |
|
|
|
| Secondary | Overall Survival (OS) | Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment. | Posted | Median | 95% Confidence Interval | Months | Assessed from baseline to 12 months. |
|
|
|
| 6 |
| 13 |
| 13 |
| 13 |
| EG001 | Vinorelbine | Vinorelbine 30 mg/m2 iv, administrated weekly | 3 | 10 | 10 | 10 |
| Acute Abdomen | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Febrile Neutropoenia | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Deterioration Of General Health | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Papilloedema | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ear Discomfort | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Orthostatic Intolerance | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Weight Decreased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Liver Function Test Abnormal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diabetes Mellitus Insulin-Dependent | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Tumour Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mental Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oliguria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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.
| D018301 |
| Neoplasms, Mesothelial |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |