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

Advanced Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503477
• Other study ID #: D8480C00023
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2007
• Last updated: June 11, 2009
• Start date: October 2005
• Est. completion date: January 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• AZD2171
oral tablet

Locations

Country	Name	City	State
Japan	Research Site	Shizuoka
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		Assessed at each visit for 4 weeks	No
Secondary	efficacy, PK		Assessed at each visit for 4 weeks	No