Phase I Chinese PK

Advanced Solid, Malignant Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503711
• Other study ID #: D4200L00004
• 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

• Advanced Solid, Malignant Tumors
• Neoplasms

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