A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumor

• Registration Number: NCT00502567
• Lead Sponsor: AstraZeneca

Brief Summary

A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Primary Completion: 2007-11
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-26
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• histologically confirmed metastatic cancer that is not amenable to surgery or radiation therapy with curative intent
• measurable lesion by CT or other techniques according to RECIST

Exclusion Criteria

• Inadequate bone marrow reserve
• history of poorly controlled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the safety and tolerability of once daily oral doses of AZD2171 when given in combination with one of these anticancer regimens; FOLFOX, Pemetrexed, Irinotecan, Docetaxel	After 5 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Examine the PK interaction of AZD2171 with one of the 4 different chemotherapeutic regimens. Make a preliminary evaluation of clinical response as measured by objective response rate.	Assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇺🇸 Nashville, Tennessee, United States