NCT00503477

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

1.7 years

First QC Date

July 16, 2007

Last Update Submit

June 11, 2009

Conditions

Advanced Solid Tumor

Keywords

JapanPhase Isolid tumorAZD2171

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Assessed at each visit for 4 weeks

Secondary Outcomes (1)

  • efficacy, PK

    Assessed at each visit for 4 weeks

Interventions

AZD2171DRUG

oral tablet

Also known as: cediranib, RECENTIN™

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Shizuoka, Japan

Location

Research Site

Tokyo, Japan

Location

MeSH Terms

Interventions

cediranib

Study Officials

  • Jane Robertson

    AstraZeneca

    STUDY DIRECTOR

  • Tomohide Tamura, MD

    National Cancer Centre Hospital, Tokyo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

October 1, 2005

Primary Completion

July 1, 2007

Study Completion

January 1, 2009

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

JP(2)