E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To continue to provide treatment to those patients that may still be on treatment at the moment of the final data base closure/clinical cut-off of a clinical trials in which Herceptin® is investigated and that further benefit from treatment with Herceptin®. |
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MedDRA Classification |
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 provide long term follow-up and safety data in patients receiving Herceptin® following completion of a global Roche sponsored Herceptin® trial. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent
2. Ongoing patients from any completed global Roche Herceptin® sponsored trial.
3. Patients enrolled in any Roche Herceptin® study who have at least stable disease (or whose disease has not recurred) during Herceptin® therapy at the end of the lead-in trial.
4. Patient’s study termination data, including tumor assessment and laboratory data, have been collected on the Case Report Form (CRF) for the lead-in trials.
5. Patients who developed signs of chronic heart failure during the lead-in trial can only enter this protocol after a thorough risk/benefit assessment by the investigator.
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E.4 | Principal exclusion criteria |
1. Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator.
2. Patients with severe dyspnea at rest requiring supplementary oxygen therapy.
3. Severe uncontrolled systemic disease
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E.5 End points |
E.5.1 | Primary end point(s) |
• To provide Herceptin® to patients with HER2 overexpressing disease following completion of any global Roche sponsored Herceptin® study.
• To follow long term outcomes in patients who are being treated with Herceptin®.
• To follow long term overall safety with Herceptin®
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Provide continuous treatment to patients who may benefit from it |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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There is no pre-specified length of trial. This trial will remain open until the last patient has withdrawn. |
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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 | |