NCT00385203

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 16, 2012

Completed
Last Updated

July 16, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

October 5, 2006

Results QC Date

March 28, 2012

Last Update Submit

June 11, 2012

Conditions

Gastrointestinal Stromal TumorsSoft Tissue Sarcomas

Keywords

cancertumouradvanced cancerMetastatic Gastro-Intestinal Stromal Tumoursgastro-intestinal cancerRECENTIN

Outcome Measures

Primary Outcomes (2)

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

    \[F 18\] 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.

    Baseline and 8 days after dosing.

  • Tumour Metabolic Activity as Assessed by Change in Central Review of Standardised Uptake Value (SUVMax) at Day 29, in Patients With GIST Tumours. SUVmax at Day 29 Minus SUVmax at Baseline.

    SUVmax at Day 29 minus SUVmax at baseline, based on central review, GIST patients

    FDG-PET assessment at Baseline and 29 days after dosing.

Secondary Outcomes (5)

  • Objective Tumour Response, Investigator Review

    RECIST at Baseline, Weeks 8, 16 and every 12 weeks thereafter until progression.

  • -Tumour Activity as Measured by Major Axis (Axial Plane) at Week 8 in GIST/STS Patients by Central Review of CT Images.

    CT assessments at Baseline and Week 8

  • Anti-tumour Activity as Measured by Major Axis (Axial Plane) at Week 16 in GIST/STS Patients by Central Review of CT Images.

    CT assessments at Baseline and Week 16.

  • Tumour Activity as Measured by Total Lesion Volume at Week 8 in GIST Patients by Central Review of CT Images.

    CT assessments at Baseline and Week 8

  • Anti-tumour Activity as Measured by Total Lesion Volume at Week 16 in GIST Patients by Central Review of CT Images.

    CT assessments at Baseline and Week 16

Interventions

AZD2171DRUG

45 mg oral tablet once daily dose

Also known as: cediranib, RECENTIN™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Manchester, United Kingdom

Location

Research Site

Sutton, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24714778DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal TumorsSarcomaNeoplasms

Interventions

cediranib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Jane Robertson, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2009

Last Updated

July 16, 2012

Results First Posted

July 16, 2012

Record last verified: 2012-06

Locations

GB(2)