Clinical trial NCT01661179: Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
Keywords: Medullary Thyroid Carcinoma
Medullary Thyroid Cancer
Vandetanib
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib
timeFrame: Sept 2012 to May 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Kobe-shi
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations, MD
role: STUDY_DIRECTOR
References: