Phase I Chinese PK

Phase 1

Completed

• Conditions: Advanced Solid, Malignant Tumors
• Interventions: Drug: Vandetanib; Drug: Vandetanib 300 mg

• Registration Number: NCT00503711
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-18
• Study First Posted: 2007-07-19
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
100 mg Vandetanib eod	Vandetanib	100 mg Vandetanib every other day dosing
300 mg Vandetanib od	Vandetanib 300 mg	300 mg Vandetanib once daily dosing
100 mg Vandetanib od	Vandetanib	100 mg Vandetanib once daily dosing

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) (0-24) (ng.h/mL) after single dose	Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1

Trial Locations

Locations (1)

Research Site; 🇨🇳 Guangzhou, China