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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01661179
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : May 19, 2015
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma Drug: Vandetanib 300mg Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Vandetanib 300mg
300 mg/day vandetanib
 Drug: Vandetanib 300mg
300 mg oral dose once daily (100 mg x 3 tablets)
Other Name: ZD6474


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661179


Locations
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Japan
Research Site
Fukuoka-shi, Japan
Research Site
Kobe-shi, Japan
Research Site
Koto-ku, Japan
Research Site
Shinjuku-ku, Japan
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations, MD Sanofi
More Information
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Additional Information:

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01661179    
Other Study ID Numbers: D4200C00098
First Posted: August 9, 2012    Key Record Dates
Results First Posted: May 19, 2015
Last Update Posted: December 5, 2016
Last Verified: October 2016
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Medullary Thyroid Carcinoma
Medullary Thyroid Cancer
Vandetanib
Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue