The Biological Activity of AZD2171 in GIST - Tabular View

Tracking Information

First Received Date ^ICMJE

October 5, 2006

Last Updated Date

November 19, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the preliminary anti-tumour activity of AZD2171 (45 mg/day) in GIST patients by assessment with FDG-PET [ Time Frame: following 8 days and 4 weeks of dosing (central review) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To determine the preliminary anti-tumour activity of AZD2171 (45 mg/day) in GIST patients by assessment with FDG-PET following 8 days and 4 weeks of dosing (central review).

Change History

Complete list of historical versions of study NCT00385203 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To study the efficacy of AZD2171 (45 mg/day) by comparing objective response rates (RECIST) and tumour size following longer-term treatment in both GIST and STS patients [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To study the efficacy of AZD2171 (45 mg/day) by comparing objective response rates (RECIST) and tumour size following longer-term treatment in both GIST and STS patients

Descriptive Information

Brief Title ^ICMJE

The Biological Activity of AZD2171 in GIST

Official Title ^ICMJE

An Open-Label, Phase II Study to Evaluate the Biological Activity of AZD2171 as Measured by FDG-PET Response, in Patients With Metastatic Gastro-Intestinal Stromal Tumours (GIST) Resistant or Intolerant to Imatinib Mesylate

Brief Summary

To determine the anti-tumour activity and biological effects of AZD2171 at a dose of 45mg, primarily in GIST patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic STS resistant to standard therapy.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Gastrointestinal Stromal Tumors
Soft Tissue Sarcomas

Intervention ^ICMJE

Drug: AZD2171

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histological or cytological confirmation of GIST which is resistant or intolerant to imatinib mesylate, or metastatic STS, which is refractory to standard therapies or for which no standard therapy exists

Exclusion Criteria:

Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes.
Patients with a history of poorly controlled high blood pressure

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00385203

Responsible Party

Study ID Numbers ^ICMJE

D8480C00046

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jane Robertson, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP