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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00503477
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Duration (Months): 39
• Patients Per Site: 20
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: AZD2171	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jan 1, 2009

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [Assessed at each visit for 4 weeks]

Secondary Outcome Measures

1. efficacy, PK [Assessed at each visit for 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Shizuoka		Japan
2	Research Site	Tokyo		Japan

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Jane Robertson, AstraZeneca
• Principal Investigator: Tomohide Tamura, MD, National Cancer Centre Hospital, Tokyo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00503477
• Other Study ID Numbers: D8480C00023
• First Posted: Jul 18, 2007
• Last Update Posted: Jun 12, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Japan; Phase I; solid tumor; AZD2171
• Additional relevant MeSH terms: Cediranib

Study Results

No Results Posted as of Jun 12, 2009