ZD6474 Phase IIa Dose Finding Multicentre Study

Genzyme

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Carcinoma

Treatments: Drug: ZD6474 (vandetanib) 300mg; Drug: ZD6474 (vandetanib) 100mg; Drug: ZD6474 (vandetanib) 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00252746

D4200C00039

Details and patient eligibility

About

To assess the objective response rates (by RECIST) to ZD6474 100, 200 and 300 mg/day respectively

Enrollment: 53 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent.
• Life expectancy of 12 weeks or longer.

Exclusion criteria

• Pregnancy, breast feeding or female patients wishing to become pregnant.
• Treatment with a non-approved or investigational drug within 30 days before enrolment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups

ZD6474 100mg

Experimental group

Description:

Daily dose

Treatment:

Drug: ZD6474 (vandetanib) 100mg

ZD6474 200mg

Experimental group

Description:

daily dose

Treatment:

Drug: ZD6474 (vandetanib) 200mg

ZD6474 300mg

Experimental group

Description:

daily dose

Treatment:

Drug: ZD6474 (vandetanib) 300mg