NCT00098345

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 24, 2011

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2017

Completed
Last Updated

May 7, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

December 7, 2004

Results QC Date

April 27, 2011

Last Update Submit

April 6, 2018

Conditions

Thyroid Cancer

Keywords

Caprelsa (vandetanib)ZD6474

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Progression Free Survival

    Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.

  • Duration of Objective Response

    Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.

  • Disease Control Rate

    Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.

  • Biochemical Response Calcitonin (CTN)

    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

    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.

  • +1 more secondary outcomes

Study Arms (1)

Caprelsa (vandetanib) 300 mg

EXPERIMENTAL

Daily oral dose of Caprelsa (vandetanib) 300mg

Drug: ZD6474 (vandetanib)

Interventions

ZD6474 (vandetanib)DRUG

oral once daily tablet

Also known as: Caprelsa™ (vandetanib), SAR390530
Caprelsa (vandetanib) 300 mg

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

San Francisco, California, United States

Location

Research Site

New Haven, Connecticut, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Durham, North Carolina, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Villejuif, France

Location

Related 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.

    PMID: 20065189BACKGROUND

Related Links

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2004

First Posted

December 8, 2004

Study Start

November 1, 2004

Primary Completion

February 1, 2008

Study Completion

April 19, 2017

Last Updated

May 7, 2018

Results First Posted

May 24, 2011

Record last verified: 2018-04

Locations

US(5)FR(1)