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Phase I Chinese PK

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503711
First Posted: July 19, 2007
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

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
  • 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™

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503711


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

Publications:
Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00503711     History of Changes
Other Study ID Numbers: D4200L00004
First Submitted: July 18, 2007
First Posted: July 19, 2007
Last Update Posted: August 31, 2016
Last Verified: August 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
ZD6474 PK

Additional relevant MeSH terms:
Neoplasms