The Biological Activity of AZD2171 in GIST - Full Text View

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Cediranib

U.S. FDA Resources

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:	35
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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:

Jane Robertson, MD

AstraZeneca

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	D8480C00046
Study First Received:	October 5, 2006
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00385203 History of Changes
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

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Digestive System Diseases
Neoplasms by Site

Digestive System Neoplasms
Gastrointestinal Diseases
Sarcoma
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on November 22, 2009