Trial Outcomes & Findings for Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma (NCT NCT01661179)
NCT ID: NCT01661179
Last Updated: 2016-12-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Sept 2012 to May 2014
Results posted on
2016-12-05
Participant Flow
From 12 November 2012 to 18 June 2013, 14 participants were treated by 4 centers in Japan to receive vandetanib.
16 participants were screened; 14 participants were treated.
Participant milestones
| Measure |
Vandetanib 300 mg
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Vandetanib 300 mg
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Other Eligibility criteria
|
4
|
Baseline Characteristics
Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma
Baseline characteristics by cohort
| Measure |
Vandetanib 300 mg
n=14 Participants
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
|
|---|---|
|
Age, Continuous
|
52.6 Years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
Age, Customized
>=20 - <50 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
>=50 - <65 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Sept 2012 to May 2014Population: All patients with post-baseline efficacy assessments
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.
Outcome measures
| Measure |
Vandetanib 300 mg
n=13 Participants
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
|
|---|---|
|
Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib
|
38.5 percentage of participants
Interval 13.86 to 68.42
|
Adverse Events
Vandetanib 300 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib 300 mg
n=14 participants at risk
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Malaise
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
7.1%
1/14 • Number of events 1
|
Other adverse events
| Measure |
Vandetanib 300 mg
n=14 participants at risk
Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
|
|---|---|
|
Eye disorders
Chalazion
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Corneal opacity
|
35.7%
5/14 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14 • Number of events 6
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 5
|
|
General disorders
Non-cardiac chest pain
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pyrexia
|
28.6%
4/14 • Number of events 8
|
|
Infections and infestations
Anisakiasis
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Electrocardiogram QT prolonged
|
21.4%
3/14 • Number of events 5
|
|
Investigations
Haemoglobin increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Weight decreased
|
14.3%
2/14 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
2/14 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
14.3%
2/14 • Number of events 3
|
|
Blood and lymphatic system disorders
Eosinophilia
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
21.4%
3/14 • Number of events 3
|
|
Cardiac disorders
Supraventricular extrasystoles
|
7.1%
1/14 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
2/14 • Number of events 2
|
|
Eye disorders
Dry eye
|
14.3%
2/14 • Number of events 2
|
|
Eye disorders
Eyelid function disorder
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Keratitis
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Keratopathy
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Meibomian gland dysfunction
|
14.3%
2/14 • Number of events 2
|
|
Eye disorders
Vision blurred
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
78.6%
11/14 • Number of events 17
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Glossitis
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
28.6%
4/14 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Malaise
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Mucosal erosion
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Oedema
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Oedema mucosal
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Cystitis
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Dermatitis infected
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
21.4%
3/14 • Number of events 4
|
|
Infections and infestations
Paronychia
|
21.4%
3/14 • Number of events 3
|
|
Infections and infestations
Rash pustular
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Vaginitis bacterial
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Wound infection
|
7.1%
1/14 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Blood calcium increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
14.3%
2/14 • Number of events 2
|
|
Investigations
Blood magnesium decreased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Red blood cell count increased
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Weight increased
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
35.7%
5/14 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
2/14 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
2/14 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14 • Number of events 2
|
|
Psychiatric disorders
Restlessness
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Punctate keratitis
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
28.6%
4/14 • Number of events 4
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
35.7%
5/14 • Number of events 5
|
|
Renal and urinary disorders
Renal impairment
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
21.4%
3/14 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
4/14 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
28.6%
4/14 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.9%
6/14 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.7%
5/14 • Number of events 5
|
|
Vascular disorders
Hypertension
|
64.3%
9/14 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER