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Trial record 32 of 418 for:    mesothelioma

An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00597116
Recruitment Status : Terminated (Recruitment stopped according to early stopping rule (by protocol))
First Posted : January 17, 2008
Results First Posted : October 15, 2012
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mesothelioma
Interventions Drug: Vinorelbine
Drug: Vandetanib
Enrollment 25
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Vandetanib Vinorelbine
Hide Arm/Group Description Vandetanib 300 mg/day oral Vinorelbine 30 mg/m2 iv, administrated weekly
Period Title: Overall Study
Started 14 11
Completed 0 [1] 0 [1]
Not Completed 14 11
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             0             2
Physician Decision             0             1
Death             0             1
Lost to Follow-up             1             0
Progressive disease             11             6
[1]
Randomised patients ongoing study treatment at data cut-off
Arm/Group Title Vandetanib Vinorelbine Total
Hide Arm/Group Description Vandetanib 300 mg/day oral Vinorelbine 30 mg/m2 iv, administrated weekly Total of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
67
(54 to 77)
64
(27 to 76)
65.5
(27 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
1
   7.7%
0
   0.0%
1
   4.3%
Male
12
  92.3%
10
 100.0%
22
  95.7%
1.Primary Outcome
Title Number of Participants With Disease Control.
Hide Description 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.
Time Frame Assessed at 2 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vandetanib Vinorelbine
Hide Arm/Group Description:
Vandetanib 300 mg/day oral
Vinorelbine 30 mg/m2 iv, administrated weekly
Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: Participants
0 5
2.Secondary Outcome
Title Number of Participants With Objective Response.
Hide Description 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.
Time Frame Assessed at 2 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vandetanib Vinorelbine
Hide Arm/Group Description:
Vandetanib 300 mg/day oral
Vinorelbine 30 mg/m2 iv, administrated weekly
Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: Participants
0 0
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description 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.
Time Frame Assessed from baseline to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vandetanib Vinorelbine
Hide Arm/Group Description:
Vandetanib 300 mg/day oral
Vinorelbine 30 mg/m2 iv, administrated weekly
Overall Number of Participants Analyzed 12 10
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.1 to 1.8)
3.8
(2.1 to 7.3)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Assessed from baseline to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vandetanib Vinorelbine
Hide Arm/Group Description:
Vandetanib 300 mg/day oral
Vinorelbine 30 mg/m2 iv, administrated weekly
Overall Number of Participants Analyzed 12 10
Median (95% Confidence Interval)
Unit of Measure: Months
7.8
(2.5 to 12.5)
6.4
(3.6 to 14.9)
Time Frame [Not Specified]
Adverse Event Reporting Description 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)
 
Arm/Group Title Vandetanib Vinorelbine
Hide Arm/Group Description Vandetanib 300 mg/day oral Vinorelbine 30 mg/m2 iv, administrated weekly
All-Cause Mortality
Vandetanib Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   6/13 (46.15%)   3/10 (30.00%) 
Blood and lymphatic system disorders     
Febrile Neutropoenia * 1  2/13 (15.38%)  0/10 (0.00%) 
Cardiac disorders     
Angina Pectoris * 1  0/13 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Acute Abdomen * 1  1/13 (7.69%)  0/10 (0.00%) 
Gastrointestinal Haemorrhage * 1  1/13 (7.69%)  0/10 (0.00%) 
Inguinal Hernia * 1  1/13 (7.69%)  0/10 (0.00%) 
General disorders     
Pyrexia * 1  1/13 (7.69%)  0/10 (0.00%) 
Deterioration Of General Health * 1  1/13 (7.69%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/13 (7.69%)  1/10 (10.00%) 
Vascular disorders     
Venous stasis * 1  1/13 (7.69%)  0/10 (0.00%) 
Pulmonary Embolism * 1  0/13 (0.00%)  1/10 (10.00%) 
Papilloedema * 1  0/13 (0.00%)  1/10 (10.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  0/13 (0.00%)  3/10 (30.00%) 
Febrile Neutropenia  1  0/13 (0.00%)  1/10 (10.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/13 (0.00%)  2/10 (20.00%) 
Ear Discomfort  1  0/13 (0.00%)  1/10 (10.00%) 
Endocrine disorders     
Hypothyroidism  1  0/13 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders     
Nausea  1  4/13 (30.77%)  6/10 (60.00%) 
Abdominal Pain Upper  1  0/13 (0.00%)  3/10 (30.00%) 
Constipation  1  3/13 (23.08%)  3/10 (30.00%) 
Diarrhoea  1  3/13 (23.08%)  1/10 (10.00%) 
Abdominal Pain  1  2/13 (15.38%)  1/10 (10.00%) 
Flatulence  1  2/13 (15.38%)  0/10 (0.00%) 
Abdominal Distension  1  1/13 (7.69%)  0/10 (0.00%) 
Anal Haemorrhage  1  1/13 (7.69%)  0/10 (0.00%) 
Cheilitis  1  0/13 (0.00%)  1/10 (10.00%) 
Dyspepsia  1  0/13 (0.00%)  1/10 (10.00%) 
Oral Pain  1  0/13 (0.00%)  1/10 (10.00%) 
Rectal Haemorrhage  1  0/13 (0.00%)  1/10 (10.00%) 
Vomiting  1  0/13 (0.00%)  1/10 (10.00%) 
General disorders     
Fatigue  1  5/13 (38.46%)  6/10 (60.00%) 
Chest Pain  1  0/13 (0.00%)  3/10 (30.00%) 
General Physical Health Deterioration  1  2/13 (15.38%)  0/10 (0.00%) 
Asthenia  1  1/13 (7.69%)  1/10 (10.00%) 
Mucosal Inflammation  1  0/13 (0.00%)  1/10 (10.00%) 
Oedema  1  1/13 (7.69%)  0/10 (0.00%) 
Oedema Peripheral  1  1/13 (7.69%)  1/10 (10.00%) 
Orthostatic Intolerance  1  0/13 (0.00%)  1/10 (10.00%) 
Pain  1  0/13 (0.00%)  1/10 (10.00%) 
Pyrexia  1  1/13 (7.69%)  1/10 (10.00%) 
Infections and infestations     
Nasopharyngitis  1  1/13 (7.69%)  3/10 (30.00%) 
Rhinitis  1  2/13 (15.38%)  0/10 (0.00%) 
Bronchitis  1  0/13 (0.00%)  1/10 (10.00%) 
Gastrointestinal Infection  1  0/13 (0.00%)  1/10 (10.00%) 
Infection  1  1/13 (7.69%)  0/10 (0.00%) 
Influenza  1  1/13 (7.69%)  0/10 (0.00%) 
Pneumonia  1  0/13 (0.00%)  1/10 (10.00%) 
Urinary Tract Infection  1  0/13 (0.00%)  1/10 (10.00%) 
Neutrophil Count Decreased  1  0/13 (0.00%)  8/10 (80.00%) 
Weight Decreased  1  2/13 (15.38%)  3/10 (30.00%) 
White Blood Cell Count Decreased  1  0/13 (0.00%)  2/10 (20.00%) 
Blood Alkaline Phosphatase Increased  1  0/13 (0.00%)  1/10 (10.00%) 
Liver Function Test Abnormal  1  1/13 (7.69%)  0/10 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  7/13 (53.85%)  4/10 (40.00%) 
Diabetes Mellitus Insulin-Dependent  1  0/13 (0.00%)  1/10 (10.00%) 
Hypokalaemia  1  1/13 (7.69%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/13 (0.00%)  1/10 (10.00%) 
Musculoskeletal Pain  1  1/13 (7.69%)  0/10 (0.00%) 
Pain In Extremity  1  0/13 (0.00%)  1/10 (10.00%) 
Pain In Jaw  1  0/13 (0.00%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour Pain  1  1/13 (7.69%)  0/10 (0.00%) 
Nervous system disorders     
Paraesthesia  1  0/13 (0.00%)  4/10 (40.00%) 
Dizziness  1  1/13 (7.69%)  1/10 (10.00%) 
Dysgeusia  1  0/13 (0.00%)  1/10 (10.00%) 
Neuropathy  1  0/13 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Depression  1  1/13 (7.69%)  0/10 (0.00%) 
Mental Disorder  1  1/13 (7.69%)  0/10 (0.00%) 
Sleep Disorder  1  1/13 (7.69%)  0/10 (0.00%) 
Renal and urinary disorders     
Nocturia  1  1/13 (7.69%)  0/10 (0.00%) 
Oliguria  1  1/13 (7.69%)  0/10 (0.00%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/13 (7.69%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/13 (23.08%)  2/10 (20.00%) 
Cough  1  2/13 (15.38%)  1/10 (10.00%) 
Dysphonia  1  1/13 (7.69%)  0/10 (0.00%) 
Epistaxis  1  1/13 (7.69%)  0/10 (0.00%) 
Hiccups  1  1/13 (7.69%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  6/13 (46.15%)  0/10 (0.00%) 
Acne  1  1/13 (7.69%)  0/10 (0.00%) 
Alopecia  1  0/13 (0.00%)  1/10 (10.00%) 
Dermatitis  1  1/13 (7.69%)  0/10 (0.00%) 
Hyperhidrosis  1  1/13 (7.69%)  0/10 (0.00%) 
Night Sweats  1  1/13 (7.69%)  0/10 (0.00%) 
Pruritus  1  1/13 (7.69%)  0/10 (0.00%) 
Urticaria  1  1/13 (7.69%)  0/10 (0.00%) 
Vascular disorders     
Haematoma  1  1/13 (7.69%)  0/10 (0.00%) 
Hot Flush  1  1/13 (7.69%)  0/10 (0.00%) 
Hypertension  1  1/13 (7.69%)  0/10 (0.00%) 
Phlebitis  1  0/13 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Early termination leading to small number of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00597116     History of Changes
Other Study ID Numbers: D4200C00075
EUDRACT Number 2007-003633-16
First Submitted: January 9, 2008
First Posted: January 17, 2008
Results First Submitted: April 27, 2011
Results First Posted: October 15, 2012
Last Update Posted: October 10, 2016