Phase I Chinese PK

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00503711

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid, Malignant Tumors	Drug: Vandetanib Drug: Vandetanib 300 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Label, Phase I, Rising Multiple Dose, Single Centre Study to Determine the PK and Tolerability of ZD6474 at Different Dose Levels in Chinese Patients With Solid Malignancy Tumor

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 100 mg Vandetanib eod 100 mg Vandetanib every other day dosing	Drug: Vandetanib 100 mg every other day, 100mg once daily Other Names: ZD6474 ZACTIMA™
Experimental: 100 mg Vandetanib od 100 mg Vandetanib once daily dosing	Drug: Vandetanib 100 mg every other day, 100mg once daily Other Names: ZD6474 ZACTIMA™
Experimental: 300 mg Vandetanib od 300 mg Vandetanib once daily dosing	Drug: Vandetanib 300 mg 300mg once daily Other Names: ZD6474 ZACTIMA™

Arm

Intervention/Treatment

Experimental: 100 mg Vandetanib eod

100 mg Vandetanib every other day dosing

Drug: Vandetanib

100 mg every other day, 100mg once daily

Other Names:

ZD6474

ZACTIMA™

Experimental: 100 mg Vandetanib od

100 mg Vandetanib once daily dosing

Drug: Vandetanib

100 mg every other day, 100mg once daily

Other Names:

ZD6474

ZACTIMA™

Experimental: 300 mg Vandetanib od

300 mg Vandetanib once daily dosing

Drug: Vandetanib 300 mg

300mg once daily

Other Names:

ZD6474

ZACTIMA™

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Guangzhou		China

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

Zhang L, Li S, Zhang Y, Zhan J, Zou BY, Smith R, Martin PD, Jiang Y, Liao H, Guan Z. Pharmacokinetics and tolerability of vandetanib in Chinese patients with solid, malignant tumors: an open-label, phase I, rising multiple-dose study. Clin Ther. 2011 Mar;33(3):315-27. doi: 10.1016/j.clinthera.2011.04.005.

Responsible Party:

Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT00503711

Other Study ID Numbers:

D4200L00004

First Posted:

Jul 19, 2007

Last Update Posted:

Aug 31, 2016

Last Verified:

Aug 1, 2016

Keywords provided by Genzyme, a Sanofi Company

ZD6474 PK

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Aug 31, 2016