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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00503711
Other study ID # D4200L00004
Secondary ID
Status Completed
Phase Phase 1
First received July 18, 2007
Last updated August 29, 2016
Start date September 2006
Est. completion date November 2007

Study information

Verified date August 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Vandetanib
100 mg every other day, 100mg once daily
Vandetanib 300 mg
300mg once daily

Locations

Country Name City State
China Research Site Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No