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

NCT ID: NCT00502567

Last Updated: 2011-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD2171

oral tablet once daily

Intervention Type DRUG

FOLFOX

intravenous infusion

Intervention Type DRUG

Pemetrexed

intravenous infusion

Intervention Type DRUG

Irinotecan (administered with & without Cetuximab)

intravenous injection

Intervention Type DRUG

Docetaxel

intravenous infusion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cediranib RECENTIN™. 5-Fluorouracil, Leucovorin and Oxaliplatin Alimta® Pemetrexed disodium Campto® Camptosar® irinotecan hydrochloride Taxotere®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jane Robertson

Role: STUDY_DIRECTOR

AstraZeneca

Bijoyesh Mookerjee, MD

Role: STUDY_CHAIR

AstraZeneca

Patricia LoRusso, DO

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Ann Arbor, Michigan, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D8480C00008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.