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An Open-Label, Phase II Study to Evaluate the Biological Activity of Cediranib (AZD2171) as Measured by [F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET) Response, in Patients With Metastatic Gastro-Intestinal Stromal Tumours (GIST) Resistant or Intolerant to Imatinib Mesylate


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumors, Soft Tissue Sarcomas

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Trial Information

An Open-Label, Phase II Study to Evaluate the Biological Activity of Cediranib (AZD2171) as Measured by [F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET) Response, in Patients With Metastatic Gastro-Intestinal Stromal Tumours (GIST) Resistant or Intolerant to Imatinib Mesylate


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in Standardised Uptake Value (SUV)Max at Day 8, Central Review, (GIST) Gastrointestinal Stromal Tumours Patients.

Outcome Description:

[F 18] Fluoro 2 Deoxy D Glucose - Positron Emission Tomography (FDG-PET). Tumour metabolic activity as assessed by Change in Standardised Uptake Value (SUVMax) at Day 8 (measured by central review), in Patients with GIST tumours. SUVmax at Day 8 minus SUVmax at Baseline.

Outcome Time Frame:

Baseline and 8 days after dosing.

Safety Issue:

No

Principal Investigator

Jane Robertson, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D8480C00046

NCT ID:

NCT00385203

Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Soft Tissue Sarcomas
  • cancer
  • tumour
  • advanced cancer
  • Metastatic Gastro-Intestinal Stromal Tumours
  • gastro-intestinal cancer
  • RECENTIN
  • Gastrointestinal Stromal Tumors
  • Sarcoma

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