Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma Clinical Trial
Official title:
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
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | July 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Fukuoka-shi | |
| Japan | Research Site | Kobe-shi | |
| Japan | Research Site | Koto-ku | |
| Japan | Research Site | Shinjuku-ku |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Sept 2012 to May 2014 | No |