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

Phase 1

Completed

• Conditions: Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
• Interventions: Drug: Vandetanib 300mg

• Registration Number: NCT01661179
• Lead Sponsor: Genzyme, a Sanofi Company

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

Study Timeline

• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-09
• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2014-07
• Results First Submitted: 2014-12-08
• Results First Submitted QC: 2015-05-18
• Results First Posted: 2015-05-19
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vandetanib 300mg	Vandetanib 300mg	300 mg/day vandetanib

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Shinjuku-ku, Japan