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The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).

NCT ID: NCT00385203

Last Updated: 2012-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors Soft Tissue Sarcomas

Keywords

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cancer tumour advanced cancer Metastatic Gastro-Intestinal Stromal Tumours gastro-intestinal cancer RECENTIN

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AZD2171

45 mg oral tablet once daily dose

Intervention Type DRUG

Other Intervention Names

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cediranib RECENTIN™

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Robertson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Manchester, , United Kingdom

Site Status

Research Site

Sutton, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Judson I, Scurr M, Gardner K, Barquin E, Marotti M, Collins B, Young H, Jurgensmeier JM, Leahy M. Phase II study of cediranib in patients with advanced gastrointestinal stromal tumors or soft-tissue sarcoma. Clin Cancer Res. 2014 Jul 1;20(13):3603-12. doi: 10.1158/1078-0432.CCR-13-1881. Epub 2014 Apr 8.

Reference Type DERIVED
PMID: 24714778 (View on PubMed)

Other Identifiers

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D8480C00046

Identifier Type: -

Identifier Source: org_study_id