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Completed

NCT Number: NCT00503477

A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients

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Key information

Conditions

Advanced Solid Tumor

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Shizuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • advanced solid tumors
  • life expectancy is 12 weeks or longer

Exclusion criteria

  • patient with uncontrolled brain metastases
  • patient with inappropriate laboratory test values
  • patient with poorly controlled hypertension

Treatment and study plan

AZD2171

Drug

oral tablet

Other names: cediranib, RECENTIN™

Primary outcomes

  1. Safety and tolerability

    Time frame: Assessed at each visit for 4 weeks

Secondary outcomes

  1. efficacy, PK

    Time frame: Assessed at each visit for 4 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Important dates

Study start
2005
Primary completion
2007
Study completion
2009
First posted
Jul 18, 2007
Registry last updated
Jun 12, 2009

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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