Phase I Chinese PK

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00503711
First received: July 18, 2007
Last updated: March 23, 2015
Last verified: March 2015
  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
Endpoint Classification: Pharmacokinetics Study
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 AstraZeneca:

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 ] [ Designated as safety issue: No ]

Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00503711

Locations
China
Research Site
Guangzhou, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Guan Zhongzhen, MD SYS Cancer Center
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

Publications:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00503711     History of Changes
Other Study ID Numbers: D4200L00004
Study First Received: July 18, 2007
Last Updated: March 23, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
ZD6474 PK

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015