Efficacy and Tolerability of ZD6474 in Patients With Thyroid Cancer

NCT ID: NCT00098345

Last Updated: 2018-05-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2017-04-19

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caprelsa (vandetanib) 300 mg

Daily oral dose of Caprelsa (vandetanib) 300mg

Group Type EXPERIMENTAL

ZD6474 (vandetanib)

Intervention Type DRUG

oral once daily tablet

Interventions

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ZD6474 (vandetanib)

oral once daily tablet

Intervention Type DRUG

Other Intervention Names

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Caprelsa™ (vandetanib) SAR390530

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Research Site

San Francisco, California, United States

Site Status

Research Site

New Haven, Connecticut, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Durham, North Carolina, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Research Site

Villejuif, , France

Site Status

Countries

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United States France

References

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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.

Reference Type BACKGROUND
PMID: 20065189 (View on PubMed)

Related Links

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Other Identifiers

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LPS14954

Identifier Type: OTHER

Identifier Source: secondary_id

D4200C00008

Identifier Type: -

Identifier Source: org_study_id

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