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:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: gastrointestinal stromal tumor

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:

Change in SUVmax at Day 8, central review [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
Change in SUVmax at Day 29, central review [ Time Frame: Day 29 ]

Secondary Outcome Measures:

Objective tumour response, investigator review [ Designated as safety issue: No ]
Major axis (axial plane) at Week 8, central review of CT images
Major axis (axial plane) at Week 16, central review of CT images
Total lesion volume at Week 8, central review of CT images
Total lesion volume at Week 16, central review of CT images

Enrollment:	35
Study Start Date:	September 2006
Study Completion Date:	December 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

45 mg oral tablet once daily dose

Other Names:

cediranib
RECENTIN™

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
Manchester, United Kingdom
Research Site
Sutton, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Jane Robertson, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00385203 History of Changes
Other Study ID Numbers:	D8480C00046
Study First Received:	October 5, 2006
Last Updated:	April 6, 2011
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:

Gastrointestinal Stromal Tumors
Sarcoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

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

ClinicalTrials.gov processed this record on February 12, 2012