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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00502567

Collaborator

(none)

104

Enrollment

Locations

76.9

Duration (Months)

34.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: AZD2171 Drug: FOLFOX Drug: Pemetrexed Drug: Irinotecan (administered with & without Cetuximab) Drug: Docetaxel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open Label Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2171 and Selected Chemotherapy Regimens When Given in Combination to Patients With Advanced Solid Tumors

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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