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An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

Thank you

Trial Information

An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease


An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And
Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or
Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease


Inclusion Criteria:



- Written consent from Female or male patients aged 18 years and over. Previously
confirmed histological diagnosis of unresectable, locally advanced or metastatic,
hereditary or sporadic MTC Objective disease progression within the previous 14
months prior to enrolment, and/or

- Have one or more symptoms that the Investigator believes to be related to the
patient's MTC.

- World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG)
Performance status 0-2.

- Has measurable disease (at least one lesion, not irradiated within 12 weeks of study
randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or
equal 15 mm) with CT or MRI).

- Lesions must be amenable to accurate and repeat measurement.

Exclusion Criteria:

- Prior treatment (major surgery, radiation therapy, chemotherapy, or other
investigational drugs) received within 28 days before randomization.

- 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).

- Significant cardiac conditions or events such as reduced cardiac functions,
symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome,
history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than
450 ms.

- Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ
functions such as decreased creatinine clearance.

- For women only - currently pregnant or breast feeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change from baseline, overall response rate (ORR) for vandetanib 150 and 300mg with responses determined by the Investigator

Outcome Description:

ORR=percentage of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1

Outcome Time Frame:

Randomisation to week 60 (maximum)

Safety Issue:

No

Principal Investigator

James Vasselli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

AZ MSD

Authority:

United States: Food and Drug Administration

Study ID:

D4200C00097

NCT ID:

NCT01496313

Start Date:

June 2012

Completion Date:

May 2015

Related Keywords:

  • Thyroid Cancer
  • medullary thyroid cancer
  • metastatic
  • thyroid cancer
  • carcinoma of the thyroid
  • receptor tyrosine kinase inhibitor
  • VEGFR
  • Unresectable locally advanced thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Research SiteAbilene, Texas