Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

Thyroid Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098345
• Other study ID #: D4200C00008
• Secondary ID: LPS14954
• Status: Completed
• Phase: Phase 2
• Start date: November 2004
• Est. completion date: April 19, 2017

Study information

• Verified date: April 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 19, 2017
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• ZD6474 (vandetanib)
oral once daily tablet

Locations

Country	Name	City	State
France	Research Site	Villejuif Cedex
United States	Research Site	Durham	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	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.	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Secondary	Progression Free Survival	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.	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Secondary	Duration of Objective Response	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.	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Secondary	Disease Control Rate	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.	Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.
Secondary	Biochemical Response Calcitonin (CTN)	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).	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
Secondary	Symptomatic Response	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.	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.
Secondary	World Health Organisation (WHO) Performance Status	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)	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.

External Links

•   CSR-D4200C00008.pdf