Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
Conditions
Keywords
Medullary Thyroid Carcinoma, Medullary Thyroid Cancer, Vandetanib
Brief summary
Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.
Detailed description
A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma
Interventions
DRUGVandetanib 300mg
300 mg oral dose once daily (100 mg x 3 tablets)
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written consent from female or male Japanese patients aged 20 years and over. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status. * Previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic Medullary Thyroid Carcinoma(MTC). * Patients who have a good overall health status(World Health Organization (WHO) Performance status 0-2). * Patients who have appropriate renal conditions confirmed by test results for taking part in the study. * For patients with measurable disease(at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
Exclusion criteria
* Patients with brain metastases or spinal cord compression. * Patients with significant abnormal ECG (QTcB correction unmeasurable or more than 480 ms)findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease. * Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance. * Patients with significant abnormal laboratory findings (to include abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases). * Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before registration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib | Sept 2012 to May 2014 | 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. |
Countries
Japan
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib 300 mg Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Other Eligibility criteria | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Vandetanib 300 mg |
|---|---|
| Age, Continuous | 52.6 Years STANDARD_DEVIATION 10.21 |
| Age, Customized >=20 - <50 years | 6 Participants |
| Age, Customized >=50 - <65 years | 7 Participants |
| Age, Customized >=65 years | 1 Participants |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 4 / 14 |
Outcome results
Primary
Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib
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
Population: All patients with post-baseline efficacy assessments
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vandetanib 300 mg | Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib | 38.5 percentage of participants |