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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. |
Register:
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EUCTR |
Last refreshed on:
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1 May 2012 |
Main ID: |
EUCTR2004-004375-11-DE |
Date of registration:
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15/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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AN OPEN LABEL, RANDOMISED, PHASE II STUDY OF AS1404 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN EPITHELIAL CANCER
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Scientific title:
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AN OPEN LABEL, RANDOMISED, PHASE II STUDY OF AS1404 IN COMBINATION WITH CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH PLATINUM-SENSITIVE RECURRENT OVARIAN EPITHELIAL CANCER |
Date of first enrolment:
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11/04/2005 |
Target sample size:
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70 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004375-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Germany
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: i) Age equal to, or greater than 18 years.
ii) ECOG performance status 0-2.
iii) Life expectancy greater than or equal to 3 months.
iv) Have first recurrent ovarian epithelial cancer including recurrent primary peritoneal serous carcinoma, confirmed by imaging, with a progression-free interval of greater than 6 months after response to platinum-based chemotherapy.
v) At least six months since prior chemotherapy or radiotherapy (except palliative radiation where the target lesion is not in the field of the radiation) and recovery from any related toxicities.
vi) Have histologically confirmed ovarian epithelial cancer including primary peritoneal serous carcinoma, with at least one unidimensionally measurable lesion according to the RECIST criteria (Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan)).
Haematological and biochemical indices at screening within the following ranges:
vii) An absolute neutrophil count of =2.0 x 10E9/l,
viii) A platelet count of =100 x 10E9/l,
ix) A haemoglobin level of > 10 g/dl,
x) Adequate hepatic and renal function as defined by serum bilirubin < 25 micromol/l; alkaline phosphatase, ALT and AST < 2.5 times the upper limit of normal; serum creatinine < 120 micromol/l or creatinine clearance =60 mL/min.
xi) Be willing and able to provide written informed consent and in the opinion of the Investigator be able to comply with the study assessments and follow-up.
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: i) Patients who have undergone or those who have had major surgery within the past 4 weeks, chemotherapy or radiation therapy (except palliative).
ii) Who progressed during prior platinum based chemotherapy and or have a known history of hypersensitivity to paclitaxel, carboplatin or any of their excipients.
iii) Previous exposure to AS1404 or other vascular targeting agents.
iv) Received blood transfusions or growth factors to aid haematological recovery within two weeks of scheduled baseline visit.
v) Concurrent severe and/or uncontrolled co-morbid medical condition within 2 weeks of screening.
vi) Clinically significant cardiac arrhythmias and known QTc prolongation.
vii) Evidence of severe or uncontrolled systemic disease that in the opinion of the Investigator might interfere with the patient's participation in the study, including but limited to unstable or uncompensated respiratory disorder, cardiac failure, hepatic, renal or metabolic disorders including uncontrolled diabetes mellitus.
viii) A history of alcoholism, drug addiction; or any psychiatric condition which in the opinion of the Investigator would impair the patient’s ability to comply with study procedures.
ix) Pregnant or lactating women. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, in the opinion of the Investigator (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). Treatment with the following medications within two weeks of AS1404 administration or the expected need for such treatments during the study period:
x) Medications known to modulate serotonin including but not limited to: Antidepressants (including but not limited to monoamine oxidase inhibitors (MAOIs), tetracyclics, tricyclics, SSRIs)
Pethidine Amphetamines Tryptophan Dextromethorphan Tramadol
xi) Medications known to affect the QT interval including but not limited to:
Antiarrhythmics: Quinidine, Disopyramide, Procainamide (NAPA), Sotalol, Ibutilide, Amiodarone Calcium-channel blockers: Bepridil, Lidoflazine CNS-active agents: Thioridazine, Tricyclic antidepressants, Pimozide Antibiotics: Erythromycin, Pentamidine, cotrimoxazole Antihistamines: Terfenadine, Astemizole Miscellaneous: Terodiline, liquid protein diets, ketanserin organophosphorus insecticides, Cisapride, Probucol
xii) Concurrent or previous malignancy of a different tumour type except for adequately treated non-melanoma skin cancer or CIN.
xiii) Clinical or radiological evidence of CNS metastases.
xiv) Symptomatic peripheral neuropathy =NCI-CTC grade II.
xv) Unresolved bowel obstruction.
xvi) Symptomatic brain metastases.
xvii) Evidence of any other significant clinical disorder or laboratory finding that in the opinion of the Investigator compromises the patient safety during study participation.
xviii) Participation in any investigational drug study in which the study drug has not subsequently obtained a product license.
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Platinum Sensitive Recurrent Ovarian Epithelial Cancer
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Intervention(s)
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Product Name: AS1404 (DMXAA) Pharmaceutical Form: Solution for injection Current Sponsor code: AS1404 Other descriptive name: DMXAA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200-
Trade Name: paclitaxel (generic) Product Name: paclitaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: paclitaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
Trade Name: carboplatin (generic) Product Name: carboplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: carboplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Primary end point(s): The tumour response rate and time to progression.
The duration of response and stable disease·
One year and median survival.
Safety and tolerability of the combination.
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Main Objective: The overall aim of this study is to determine whether AS1404 will increase efficacy of carboplatin and paclitaxel combination in treating patients with platinum-sensitive recurrent ovarian epithelial cancer.
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Secondary Objective: To determine the safety and tolerability of the combination.
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Secondary ID(s)
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AS1404-202
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2004-004375-11-GB
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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