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

This study is currently recruiting participants.
Verified February 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01661179
First received: July 17, 2012
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: During the treatment period and than up to 60 days after treatment period ] [ Designated as safety issue: Yes ]
  • QTc Bazett's absolute values [ Time Frame: During the treatment period and than up to 60 days after treatment period ] [ Designated as safety issue: Yes ]
  • Vital signs including pulse rate, blood pressure and temperature [ Time Frame: During the treatment period and than up to 60 days after treatment period ] [ Designated as safety issue: Yes ]
  • Haematology and clinical chemistry absolute values [ Time Frame: During the treatment period and than up to 60 days after treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Pre-dose and 85, 169, 253, 337 and 421 days post first dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics of vandetanib [ Time Frame: 8,15,22,29,57,85,113,141,169,197,225,253 days post first dose ] [ Designated as safety issue: No ]
    PK parameters for multiple dose: Maximum Concentration (Cmax),Time to Maximum Plasma Concentration (tmax), and Area Under Curve (AUC)

  • Relationship between pharmacokinetics and pharmocodynamics. [ Time Frame: 8,15,22,29,57,85,113,141,169,197,225,253 days post first dose ] [ Designated as safety issue: No ]
    Relationship between vandetanib plasma concentration and effect on QTc. If appropriate, concentration-effect relationships will be explored.

  • Progression-free survival (PFS) [ Time Frame: Pre-dose and 85, 169, 253, 337 and 421 days post first dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vandetanib 300mg
300 mg/day vandetanib
 Drug: Vandetanib 300mg
300 mg oral dose once daily (100 mg x 3 tablets)

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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 desease.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661179

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
Japan
National Hospital Organization Kyushu Medical Center Recruiting
Fukuoka, Japan
Kobe City Medical Center General Hospital Not yet recruiting
Hyogo, Japan
Research Site-Tokyo Women's Medical University Hospital Recruiting
Tokyo, Japan, 162-8666
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: James Vasselli, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01661179     History of Changes
Other Study ID Numbers: D4200C00098
Study First Received: July 17, 2012
Last Updated: February 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Medullary Thyroid Carcinoma
Medullary Thyroid Cancer
Vandetanib

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013