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OpenTrials
Completed

NCT Number: NCT00264004

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

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.

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Key information

Conditions

Tumors Cardiovascular Diseases Hypertension Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Freiburg im Breisgau, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2171

Drug

30 mg & 45 mg oral tablet

Other names: Cediranib, RECENTIN™

Primary outcomes

  1. 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

  2. Proportion of Planned Dose Received During First 12 Weeks of Therapy With AZD2171

    Time frame: 12 week treatment period

    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 outcomes

  1. 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

  2. Objective Response Rate

    Time frame: 12 week treatment period

    Number of patients with complete or partial response (CR/PR), based on RECIST

  3. Best Percentage Change in Tumour Size

    Time frame: Randomisation until end of treatment period

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Dec 12, 2005
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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