Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer - Full Text View

Purpose

The purpose of this open label, two stage, phase II study is to evaluate the efficacy and tolerability of ZD6474 in patients with locally advanced or metastatic hereditary medullary thyroid carcinoma.

Condition	Intervention	Phase
Thyroid Cancer	Drug: ZD6474 (vandetanib)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Two Stage, Phase II Study to Evaluate the Efficacy and Tolerability of ZD6474 in Patients With Locally Advanced or Metastatic Hereditary Medullary Thyroid Carcinoma.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid Vandetanib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ] [ Designated as safety issue: No ]
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ] [ Designated as safety issue: No ]
Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.
Duration of Objective Response [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ] [ Designated as safety issue: No ]
Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.
Disease Control Rate [ Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0. ] [ Designated as safety issue: No ]
Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.
Biochemical Response Calcitonin (CTN) [ Time Frame: Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation ] [ Designated as safety issue: No ]
A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).
Symptomatic Response [ Time Frame: Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug. ] [ Designated as safety issue: No ]
Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.
World Health Organisation (WHO) Performance Status [ Time Frame: Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated. ] [ Designated as safety issue: No ]
Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)

Enrollment:	30
Study Start Date:	November 2004
Estimated Study Completion Date:	December 2012
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Caprelsa (vandetanib) 300 mg Daily oral dose of Caprelsa (vandetanib) 300mg	Drug: ZD6474 (vandetanib) oral once daily tablet Other Name: Caprelsa™ (vandetanib)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Locally advanced or hereditary medullary thyroid cancer
Signed informed consent
One or more measurable lesions

Exclusion Criteria:

Brain metastases or spinal cord compression
Specific laboratory ranges
Specific heart problems
Prior chemotherapy and/or radiation therapy
Participation in other trials within 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098345

Locations

United States, California
Research Site
San Francisco, California, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, Texas
Research Site
Houston, Texas, United States
France
Research Site
Cedex, France

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca ZD6474 Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00098345 History of Changes
Other Study ID Numbers:	D4200C00008
Study First Received:	December 7, 2004
Results First Received:	April 27, 2011
Last Updated:	September 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Caprelsa (vandetanib)
ZD6474

Additional relevant MeSH terms:

Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site

Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013