E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065147 |
E.1.2 | Term | Malignant solid tumor |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |