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Main
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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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28 March 2022 |
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Main ID: |
EUCTR2009-016834-28-BE |
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Date of registration:
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16/02/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open-label, multi-center, continued access trial of investigational drug ASA404 for patients in previous ASA404 clinical trials
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Scientific title:
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An open-label, multi-center, continued access trial of investigational drug ASA404 for patients in previous ASA404 clinical trials |
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Date of first enrolment:
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14/04/2010 |
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Target sample size:
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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:2009-016834-28 |
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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: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients who have completed at least 2 cycles of ASA404 in conjunction with a taxane-based chemotherapy in a previous Novartis-sponsored ASA404 trial and continued treatment with ASA404 alone or in combination with either docetaxel, paclitaxel, carboplatin or in combination with the paclitaxel plus carboplatin chemotherapy regimen, is considered appropriate by the Investigator.
2. Patients must have achieved at least stable disease by radiographic criteria.
3. Written informed consent obtained prior to any non-standard of care study procedures.
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. Pregnant or breast feeding females
2. Women of child-bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment.
3. Patients who had an ASA404 dose within the past 21 days.
4. Patients who have not had an ASA404 dose within the past 64 days.
For patients being treated with docetaxel, additional exclusion criteria:
5. Known allergy or hypersensitivity to drugs formulated with polysorbate 80 or any known excipients of these drugs.
For patients being treated with paclitaxel, additional exclusion criteria:
6. Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
7. Peripheral sensory neuropathy with functional impairment (CTCAE v3.0 Grade 2
neuropathy, regardless of causality).
8. Patients taking oral, implantable or injectable contraceptives who are not willing or otherwise unable to use a concomitant barrier method.
For patients being treated with carboplatin, additional exclusion criteria:
9. Known allergy or hypersensitivity to platinum-containing drugs.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Solid tumors
MedDRA version: 12.1
Level: LLT
Classification code 10065147
Term: Malignant solid tumor
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Intervention(s)
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Product Name: ASA404
Product Code: ASA404
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: vadimezan
CAS Number: 29095-08-5
Current Sponsor code: ASA404
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
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Primary Outcome(s)
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Main Objective: To continue to collect and review safety data in patients who have completed at least 2 cycles of ASA404 in conjunction with a taxane-based chemotherapy in one of the following Novartis sponsored ASA404 studies until ASA404 is commercially available or the project has been discontinued:CASA404A2105, CASA404A2109, CASA404A2111, CASA404A2112, CASA404A2113, CASA404A1102
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Primary end point(s): The assessment of safety will be based mainly on the frequency and severity of adverse events and the number of laboratory values worsening from baseline, based upon the CTCAE grade. Other safety data (e.g., vital signs, electrocardiograms, ophthalmic assessments, and special tests) will be considered as appropriate.
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Secondary Objective: Not applicable.
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Secondary ID(s)
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CASA404A2401
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 01/03/2010
Contact:
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