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 for the Safety and Tolerability of AZD2171 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503477

Enrollment

Registered

2007-07-18

Start date

2005-10-31

Completion date

2009-01-31

Last updated

2009-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumor

Keywords

Japan, Phase I, solid tumor, AZD2171

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

Interventions

DRUGAZD2171

oral tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	Assessed at each visit for 4 weeks

Secondary

Measure	Time frame
efficacy, PK	Assessed at each visit for 4 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026