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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01661179
First received: July 17, 2012
Last updated: September 26, 2014
Last verified: September 2014
  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: Allocation: Non-Randomized
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:


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 pharmacodynamics. [ 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 ]

Enrollment: 16
Study Start Date: November 2012
Study Completion Date: July 2014
Primary Completion Date: December 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)
Other Name: ZD6474

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661179

Locations
Japan
Research Site
Fukuoka-shi, Japan
Research Site
Kobe-shi, Japan
Research Site
Koto-ku, Japan
Research Site
Shinjuku-ku, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Jeffrey Skolnik, MD AstraZeneca
Principal Investigator: Takahiro Okamoto, MD Tokyo Women's Medical University Hospital
Principal Investigator: Keita Uchino, MD National Hospital Organization Kyushu Medical Center
  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: September 26, 2014
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:
Thyroid Diseases
Carcinoma
Thyroid Neoplasms
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014