An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

Genzyme

Status and phase: Completed; Phase 3

Conditions: Thyroid Cancer

Treatments: Drug: ZD6474 (Vandetanib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410761

LPS14811 (Other Identifier)

D4200C00058

2005-005077-29 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

Enrollment: 437 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.
• Presence of measurable tumor
• Able to swallow medication

Exclusion criteria

• Major surgery within 4 weeks before randomization
• Last dose of prior chemotherapy received less than 4 weeks prior to randomization
• Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy)
• Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
• Significant cardiac events
• Previous ZD6474 treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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437 participants in 2 patient groups

1

No Intervention group

Description:

Placebo vandetanib

2

Experimental group

Description:

Vandetanib

Treatment:

Drug: ZD6474 (Vandetanib)