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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-005717-38-GB |
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Date of registration:
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14/10/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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. |
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Date of first enrolment:
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15/08/2006 |
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Target sample size:
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45 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005717-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised:
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Provision of informed consent Male or female aged 18 years or older 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 WHO Performance status 0 – 2 Life expectancy of > 12 weeks One or more measurable lesions at least 10mm in the longest diameter by spiral computed tomography (CT) scan or 20 mm with conventional techniques (and for GIST patients this must be at least 20mm by any technique as a modification of RECIST). Provision of informed consent for genetic research.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Untreated unstable brain or meningeal metastases. Patients with radiological evidence of stable brain metastases are eligible providing that they are asymptomatic and either: - do not require corticosteroids or - have been treated with corticosteroids, with clinical and radiological evidence of brain metastases stabilisation at least 10 days after discontinuation of steroids. 2. Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count less than or equal 1.5 x 10 power 9 /L or platelet count less than or equal 100 x 10 power 9 /L or requiring regular blood transfusions to maintain haemoglobin >9 g/dL. 3. Serum bilirubin greater than or equal 1.5 x upper limit of reference range (ULRR). 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal 2.5 x ULRR. If liver metastases are present, ALT or AST >5 x ULRR. 5. Serum creatinine >1.5 x ULRR or a creatinine clearance of less than or equal 50mL/min calculated by Cockcroft-Gault. 6. Greater than +1 proteinuria on 2 consecutive dipsticks taken no less than 1 week apart unless urinary protein <1.5 g in a 24 hour urine collection. 7. Patients with a history of poorly controlled hypertension with resting BP >150/100 mmHg in the presence or absence of a stable regimen of anti hypertensive therapy. 8. Any evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), including known infection with Hepatitis B or C virus or human immunodeficiency virus. 9. Unresolved toxicity >CTC grade 2 from previous anti-cancer therapy except alopecia (if applicable). 10. Mean QTc with Bazett’s correction >470 msec in screening electrocardiogram (ECG) or history of familial long QT syndrome (as per International Conference on Harmonisation [ICH] guideline E14). 11.Significant haemorrhage (>30 ml bleeding/episode in previous 3 months) or haemoptysis (>5 ml fresh blood in previous 4 weeks). 12. Recent (<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed. 13. Pregnant or breast-feeding women or women of childbearing potential with a positive pregnancy test prior to receiving study medication. 14. Known severe hypersensitivity to AZD2171 or any of its excipients. 15. Other concomitant anti cancer therapy, except steroids. 16. Known severe hypersensitivity to beta blockers or calcium channel blockers. 17. History of other malignancies within 5 years except for adequately treated basal or squamous cell cancer or carcinoma in situ. 18. History of CNS disorders or uncontrolled seizures. 19. History of significant gastrointestinal impairment (unrelated to GIST), as judged by the investigator that would significantly affect the absorption of AZD2171. 20. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study site). 21. Previous enrolment or randomisation of treatment in the present study. 22. Treatment with an investigational drug within 30 days prior to starting AZD2171, with the exception of SU11248 and imatinib mesylate which should be stopped at least 14 days before starting AZD2171.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Metastatic Gastro-Intestinal Stromal Tumours
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Intervention(s)
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Product Name: AZD2171
Pharmaceutical Form: Film-coated tablet
CAS Number: 857036-77-2
Current Sponsor code: AZD2171
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Product Name: AZD2171
Pharmaceutical Form: Film-coated tablet
CAS Number: 857036-77-2
Current Sponsor code: AZD2171
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Product Name: AZD2171
Pharmaceutical Form: Film-coated tablet
CAS Number: 857036-77-2
Current Sponsor code: AZD2171
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
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Primary Outcome(s)
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Secondary Objective: To determine the preliminary anti-tumour activity of AZD2171 (45 mg/day) in GIST patients by assessment with FDG-PET following 8 days and 4 weeks of dosing investigator review for SUVmax). To determine the efficacy of AZD2171 (45 mg/day) in GIST and STS patients by assessment of objective tumour response (RECIST) as determined by site. To determine the anti-tumour activity of AZD2171 (45 mg/day) in GIST patients from central review of CT images for a range of CT assessments (including RECIST, cavitation/ necrosis, tumour volume, area and major and minor axes). To determine the anti-tumour activity of AZD2171 (45 mg/day) in GIST patients from central review of FDG-PET images for a range of endpoints (including average SUV, metabolic volume). Compare intra-patient Css, min values for GIST and STS patients who receive long-term therapy with AZD2171. To investigate the safety and tolerability of AZD2171 in GIST and STS patients.
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Primary end point(s): The primary analysis will occur after the last patient in the 45 mg cohort has received 16 weeks of treatment and undergone their 16 week RECIST scan. At this point the pharmacokinetic data will be analysed in order to determine whether an additional cohort of up to ten patients will be recruited at the 60 mg dose.
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Main Objective: To determine the preliminary anti-tumour activity of AZD2171 (45 mg/day) in GIST patients by assessment with FDG-PET following 8 days and 4 weeks of dosing (central review of SUVmax).
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Secondary ID(s)
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D8480C00046
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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