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

Phase 1
Completed
Conditions
Advanced Solid Tumor
Registration Number
NCT00503477
Lead Sponsor
AstraZeneca
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • advanced solid tumors
  • life expectancy is 12 weeks or longer
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Exclusion Criteria
  • patient with uncontrolled brain metastases
  • patient with inappropriate laboratory test values
  • patient with poorly controlled hypertension
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Safety and tolerabilityAssessed at each visit for 4 weeks
Secondary Outcome Measures
NameTimeMethod
efficacy, PKAssessed at each visit for 4 weeks

Trial Locations

Locations (1)

Research Site

🇯🇵

Tokyo, Japan

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