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Clinical Trials/NCT00503477
NCT00503477CompletedPhase 1

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

AstraZeneca2 sites in 1 country40 target enrollmentStarted: October 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Safety and tolerability
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Safety and tolerability

Time Frame: Assessed at each visit for 4 weeks

Secondary Outcomes

  • efficacy, PK(Assessed at each visit for 4 weeks)

Investigators

Sponsor Class
Industry

Study Sites (2)

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