Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00264004
First received: December 9, 2005
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.


Condition Intervention Phase
Tumors
Drug: AZD2171
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients With Advanced Solid Tumours

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 12 Weeks of First Dose of AZD2171 [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
  • Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171 [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
    Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)


Secondary Outcome Measures:
  • Proportion of Patients Requiring Temporary (>1 Day) or Permanent Withdrawal of AZD2171 Prior to Progression and Within 6 Weeks of First Dose of AZD2171 [ Time Frame: First 6 weeks of 12 week treatment period ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: 12 week treatment period ] [ Designated as safety issue: No ]
    Number of patients with complete or partial response (CR/PR), based on RECIST

  • Best Percentage Change in Tumour Size [ Time Frame: Randomisation until end of treatment period ] [ Designated as safety issue: No ]
    Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.


Enrollment: 119
Study Start Date: November 2005
Study Completion Date: April 2011
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
30 mg AZD2171
Drug: AZD2171
30 mg & 45 mg oral tablet
Other Names:
  • Cediranib
  • RECENTIN™
Experimental: 2
45 mg AZD2171
Drug: AZD2171
30 mg & 45 mg oral tablet
Other Names:
  • Cediranib
  • RECENTIN™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Exclusion Criteria:

  • Prior treatment with a VEGF inhibitor
  • Poorly controlled hypertension
  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: NCT00264004

Locations
Germany
Research Site
Freiburg, Germany
Research Site
Hamburg, Germany
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Utrecht, Netherlands
United Kingdom
Research Site
Surrey, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00264004     History of Changes
Other Study ID Numbers: D8480C00038, EUDRACT Number 2005-003442-33
Study First Received: December 9, 2005
Results First Received: July 26, 2012
Last Updated: July 26, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Advanced Solid Tumours
phase II
Hypertension
RECENTIN

Additional relevant MeSH terms:
Hypertension
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Cediranib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014