Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00098345
• Date of registration: 07/12/2004
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
• Scientific 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.
• Date of first enrolment: November 2004
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00098345
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Thyroid Cancer

Intervention(s)

Drug: ZD6474 (vandetanib)

Primary Outcome(s)

Objective Response Rate [Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.]

Secondary Outcome(s)

Disease Control Rate [Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.]

Duration of Objective Response [Time Frame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.]

Progression Free Survival [Time Frame: Pre-dose and every 12 weeks up to RECIST progression 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]

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.]

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.]

Secondary ID(s)

D4200C00008

LPS14954

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/05/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00098345