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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


Phase 1/Phase 2
20 Years
N/A
Open (Enrolling)
Both
Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and severity of adverse events

Outcome Time Frame:

During the treatment period and than up to 60 days after treatment period

Safety Issue:

Yes

Principal Investigator

James Vasselli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

D4200C00098

NCT ID:

NCT01661179

Start Date:

November 2012

Completion Date:

March 2015

Related Keywords:

  • Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma
  • Medullary Thyroid Carcinoma
  • Medullary Thyroid Cancer
  • Vandetanib
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases

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