The Biological Activity of AZD2171 in GIST - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors Soft Tissue Sarcomas	Drug: AZD2171	Phase II

MedlinePlus related topics:

Cancer Soft Tissue Sarcoma

Drug Information available for:

Imatinib Imatinib mesylate Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	25
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2008

Intervention Details:

45 mg oral tablet once daily dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385203

Locations


United Kingdom
	Research Site
	Sutton, United Kingdom
	Research Site
	Manchester, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Emerging Oncology Medical Science Director, MD	AstraZeneca

More Information

Astrazeneca Information - outside of the US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D8480C00046
First Received:	October 5, 2006
Last Updated:	December 15, 2007
ClinicalTrials.gov Identifier:	NCT00385203
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

cancer

tumour

advanced cancer

Metastatic Gastro-Intestinal Stromal Tumours

gastro-intestinal cancer

RECENTIN

Study placed in the following topic categories:

Imatinib

Neoplasms, Connective and Soft Tissue

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Malignant mesenchymal tumor

Sarcoma

Gastrointestinal Neoplasms

Gastrointestinal Stromal Tumors

Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00385203