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Phase I Chinese PK

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: July 18, 2007
Last updated: August 29, 2016
Last verified: August 2016
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 Intervention Phase
Advanced Solid, Malignant Tumors
Drug: Vandetanib
Drug: Vandetanib 300 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Area under the curve (AUC) (0-24) (ng.h/mL) after single dose [ Time Frame: Blood sample is collected at 1, 2, 4, 6, 8, 10 & 24 hour after first single dose on day 1 ]

Enrollment: 36
Study Start Date: September 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 100 mg Vandetanib od
100 mg Vandetanib once daily dosing
Drug: Vandetanib
100 mg every other day, 100mg once daily
Other Names:
  • ZD6474
Experimental: 300 mg Vandetanib od
300 mg Vandetanib once daily dosing
Drug: Vandetanib 300 mg
300mg once daily
Other Names:
  • ZD6474


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00503711

Research Site
Guangzhou, China
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00503711     History of Changes
Other Study ID Numbers: D4200L00004
Study First Received: July 18, 2007
Last Updated: August 29, 2016

Keywords provided by Sanofi:
ZD6474 PK

Additional relevant MeSH terms:
Neoplasms processed this record on May 24, 2017