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

July 26, 2011 updated by: AstraZeneca

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

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).

Study Overview

Status

Completed

Conditions

Advanced Solid Tumor

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Michigan
  - Ann Arbor, Michigan, United States
    - Research Site
  - Detroit, Michigan, United States
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: After 5 weeks of treatment	After 5 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: Assessed at each visit	Assessed at each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Chair: Bijoyesh Mookerjee, MD, AstraZeneca
Principal Investigator: Patricia LoRusso, DO, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria