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

Primary Purpose

Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Vandetanib 300mg
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma focused on measuring Medullary Thyroid Carcinoma, Medullary Thyroid Cancer, Vandetanib

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vandetanib 300mg

Arm Description

300 mg/day vandetanib

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2012
Last Updated
October 11, 2016
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01661179
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
Keywords
Medullary Thyroid Carcinoma, Medullary Thyroid Cancer, Vandetanib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vandetanib 300mg
Arm Type
Experimental
Arm Description
300 mg/day vandetanib
Intervention Type
Drug
Intervention Name(s)
Vandetanib 300mg
Other Intervention Name(s)
ZD6474
Intervention Description
300 mg oral dose once daily (100 mg x 3 tablets)
Primary Outcome Measure Information:
Title
Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Fukuoka-shi
Country
Japan
Facility Name
Research Site
City
Kobe-shi
Country
Japan
Facility Name
Research Site
City
Koto-ku
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=356&filename=D4200C00098_Clinical_Trial_Disclosure_Synopsis.pdf
Description
CSR Synopsis

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

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