Phase I Chinese PK

Genzyme

Status and phase: Completed; Phase 1

Conditions: Advanced Solid, Malignant Tumors

Treatments: Drug: Vandetanib; Drug: Vandetanib 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503711

D4200L00004

Details and patient eligibility

About

An open, phase 1 to assess the PK of rising doses of ZD6474 when administered daily in Chinese patients with advanced solid malignant tumors.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histological and/or cytological confirmation of a malignant solid tumor
• refractory to standard therapies or for which no appropriate therapies exist
• WHO performance status 0-2

Exclusion criteria

• patients with brain tumors or symptomatic cerebral metastases
• systemic anticancer therapy within the last 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

100 mg Vandetanib eod

Experimental group

Description:

100 mg Vandetanib every other day dosing

Treatment:

Drug: Vandetanib

100 mg Vandetanib od

Experimental group

Description:

100 mg Vandetanib once daily dosing

Treatment:

Drug: Vandetanib

300 mg Vandetanib od

Experimental group

Description:

300 mg Vandetanib once daily dosing

Treatment:

Drug: Vandetanib 300 mg