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Trial record 12 of 116 for:    medullary carcinoma

Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma

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: NCT01661179
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : May 19, 2015
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
Intervention Drug: Vandetanib 300mg
Enrollment 14
Recruitment Details From 12 November 2012 to 18 June 2013, 14 participants were treated by 4 centers in Japan to receive vandetanib.
Pre-assignment Details 16 participants were screened; 14 participants were treated.
Arm/Group Title Vandetanib 300 mg
Hide Arm/Group Description Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
Period Title: Overall Study
Started 14
Completed 8
Not Completed 6
Reason Not Completed
Death             1
Withdrawal by Subject             1
Other Eligibility criteria             4
Arm/Group Title Vandetanib 300 mg
Hide Arm/Group Description Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
52.6  (10.21)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
>=20 - <50 years 6
>=50 - <65 years 7
>=65 years 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
7
  50.0%
Male
7
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 14 participants
14
1.Primary Outcome
Title Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib
Hide Description ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.
Time Frame Sept 2012 to May 2014
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with post-baseline efficacy assessments
Arm/Group Title Vandetanib 300 mg
Hide Arm/Group Description:
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(13.86 to 68.42)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib 300 mg
Hide Arm/Group Description Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
All-Cause Mortality
Vandetanib 300 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib 300 mg
Affected / at Risk (%) # Events
Total   4/14 (28.57%)    
Gastrointestinal disorders   
Ascites  1  1/14 (7.14%)  1
General disorders   
Fatigue  1  1/14 (7.14%)  1
Malaise  1  1/14 (7.14%)  1
Infections and infestations   
Pyelonephritis  1  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1  1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 300 mg
Affected / at Risk (%) # Events
Total   14/14 (100.00%)    
Blood and lymphatic system disorders   
Eosinophilia  1  1/14 (7.14%)  1
Cardiac disorders   
Palpitations  1  3/14 (21.43%)  3
Supraventricular extrasystoles  1  1/14 (7.14%)  1
Ear and labyrinth disorders   
Vertigo  1  2/14 (14.29%)  2
Eye disorders   
Chalazion  1  1/14 (7.14%)  1
Corneal opacity  1  5/14 (35.71%)  5
Dry eye  1  2/14 (14.29%)  2
Eyelid function disorder  1  1/14 (7.14%)  1
Keratitis  1  1/14 (7.14%)  1
Keratopathy  1  1/14 (7.14%)  1
Meibomian gland dysfunction  1  2/14 (14.29%)  2
Vision blurred  1  1/14 (7.14%)  1
Punctate keratitis  1  1/14 (7.14%)  1
Gastrointestinal disorders   
Abdominal pain upper  1  1/14 (7.14%)  1
Dyspepsia  1  1/14 (7.14%)  1
Gastritis  1  1/14 (7.14%)  1
Haemorrhoidal haemorrhage  1  1/14 (7.14%)  1
Nausea  1  5/14 (35.71%)  6
Cheilitis  1  1/14 (7.14%)  1
Constipation  1  2/14 (14.29%)  2
Diarrhoea  1  11/14 (78.57%)  17
Dry mouth  1  1/14 (7.14%)  1
Glossitis  1  1/14 (7.14%)  1
Stomatitis  1  4/14 (28.57%)  6
Vomiting  1  2/14 (14.29%)  2
General disorders   
Fatigue  1  3/14 (21.43%)  5
Non-cardiac chest pain  1  1/14 (7.14%)  1
Pyrexia  1  4/14 (28.57%)  8
Malaise  1  2/14 (14.29%)  2
Mucosal erosion  1  1/14 (7.14%)  1
Oedema  1  4/14 (28.57%)  4
Oedema mucosal  1  1/14 (7.14%)  1
Pain  1  1/14 (7.14%)  2
Infections and infestations   
Anisakiasis  1  1/14 (7.14%)  1
Tinea pedis  1  1/14 (7.14%)  1
Bronchitis  1  1/14 (7.14%)  1
Cystitis  1  1/14 (7.14%)  1
Dermatitis infected  1  1/14 (7.14%)  1
Gastroenteritis  1  1/14 (7.14%)  1
Herpes zoster  1  1/14 (7.14%)  1
Laryngitis  1  1/14 (7.14%)  1
Nasopharyngitis  1  3/14 (21.43%)  4
Paronychia  1  3/14 (21.43%)  3
Rash pustular  1  1/14 (7.14%)  1
Upper respiratory tract infection  1  1/14 (7.14%)  1
Urinary tract infection  1  1/14 (7.14%)  1
Vaginitis bacterial  1  1/14 (7.14%)  1
Vulvovaginal candidiasis  1  1/14 (7.14%)  1
Wound infection  1  1/14 (7.14%)  1
Injury, poisoning and procedural complications   
Thermal burn  1  1/14 (7.14%)  1
Investigations   
Alanine aminotransferase increased  1  1/14 (7.14%)  1
Aspartate aminotransferase increased  1  1/14 (7.14%)  1
Blood alkaline phosphatase increased  1  1/14 (7.14%)  1
Electrocardiogram QT prolonged  1  3/14 (21.43%)  5
Haemoglobin increased  1  1/14 (7.14%)  1
Weight decreased  1  2/14 (14.29%)  2
Blood calcium increased  1  1/14 (7.14%)  1
Blood creatinine increased  1  2/14 (14.29%)  2
Blood magnesium decreased  1  1/14 (7.14%)  1
Red blood cell count increased  1  1/14 (7.14%)  1
Weight increased  1  1/14 (7.14%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  5/14 (35.71%)  6
Dehydration  1  2/14 (14.29%)  2
Hypocalcaemia  1  2/14 (14.29%)  4
Hypokalaemia  1  1/14 (7.14%)  1
Hypomagnesaemia  1  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/14 (7.14%)  1
Arthritis  1  2/14 (14.29%)  2
Muscle spasms  1  1/14 (7.14%)  1
Musculoskeletal chest pain  1  1/14 (7.14%)  1
Neck pain  1  1/14 (7.14%)  1
Nervous system disorders   
Dysgeusia  1  2/14 (14.29%)  2
Headache  1  2/14 (14.29%)  2
Somnolence  1  1/14 (7.14%)  1
Syncope  1  1/14 (7.14%)  1
Tremor  1  1/14 (7.14%)  1
Peripheral sensory neuropathy  1  2/14 (14.29%)  2
Dizziness  1  4/14 (28.57%)  4
Psychiatric disorders   
Anxiety  1  1/14 (7.14%)  1
Insomnia  1  1/14 (7.14%)  1
Restlessness  1  1/14 (7.14%)  1
Renal and urinary disorders   
Haematuria  1  2/14 (14.29%)  3
Nephrolithiasis  1  1/14 (7.14%)  1
Proteinuria  1  5/14 (35.71%)  5
Renal impairment  1  2/14 (14.29%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/14 (14.29%)  2
Dysphonia  1  3/14 (21.43%)  3
Dyspnoea  1  1/14 (7.14%)  1
Dyspnoea exertional  1  2/14 (14.29%)  2
Epistaxis  1  2/14 (14.29%)  2
Hiccups  1  1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  4/14 (28.57%)  4
Dermatitis acneiform  1  2/14 (14.29%)  2
Dry skin  1  1/14 (7.14%)  1
Ingrowing nail  1  2/14 (14.29%)  2
Onychomadesis  1  1/14 (7.14%)  1
Palmar-plantar erythrodysaesthesia syndrome  1  4/14 (28.57%)  4
Pruritus  1  2/14 (14.29%)  2
Rash  1  6/14 (42.86%)  6
Rash maculo-papular  1  5/14 (35.71%)  5
Vascular disorders   
Hypertension  1  9/14 (64.29%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01661179     History of Changes
Other Study ID Numbers: D4200C00098
First Submitted: July 17, 2012
First Posted: August 9, 2012
Results First Submitted: December 8, 2014
Results First Posted: May 19, 2015
Last Update Posted: December 5, 2016