Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00098345
First received: December 7, 2004
Last updated: July 15, 2014
Last verified: July 2014
  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:


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: 40
Study Start Date: November 2004
Estimated Study Completion Date: March 2015
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
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: NCT00098345

Locations
United States, California
Research Site
San Francisco, California, United States
United States, Connecticut
Research Site
New Haven, Connecticut, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Texas
Research Site
Houston, Texas, United States
France
Research Site
Villejuif Cedex, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca ZD6474 Medical Science Director, MD AstraZeneca
  More Information

Additional 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: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Caprelsa (vandetanib)
ZD6474

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 27, 2014