Clinical trial NCT00098345: Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: Caprelsa (vandetanib)
ZD6474
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
measure: Duration of Objective Response
timeFrame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
measure: Disease Control Rate
timeFrame: Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
measure: Biochemical Response Calcitonin (CTN)
timeFrame: 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
measure: Symptomatic Response
timeFrame: 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.
measure: World Health Organisation (WHO) Performance Status
timeFrame: 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.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: New York
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Houston
country: United States
facility: Research Site
state: Texas
city: Villejuif Cedex
country: France
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Wells SA Jr, Gosnell JE, Gagel RF, Moley J, Pfister D, Sosa JA, Skinner M, Krebs A, Vasselli J, Schlumberger M. Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol. 2010 Feb 10;28(5):767-72. doi: 10.1200/JCO.2009.23.6604. Epub 2010 Jan 11.