E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Solid Tumours
(Future parent protocols may include other solid tumors that are not included in this section) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065430 |
E.1.2 | Term | HER-2 positive breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066697 |
E.1.2 | Term | Ovarian cancer recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 provide continued pertuzumab therapy to patients who were previously enrolled in a F. Hoffmann-La Roche (Roche)-sponsored pertuzumab study (the Parent study) and who continue to derive benefit from pertuzumab-based therapy administered in the Parent study at the time of Parent study closure. |
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E.2.2 | Secondary objectives of the trial |
To collect long-term safety and efficacy data of pertuzumab therapy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Informed consent
- Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
- Investigator’s opinion that the patient continues to benefit from pertuzumab treatment |
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E.4 | Principal exclusion criteria |
- Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study
- Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
- Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
- Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below.
- More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
- Left ventricular ejection fraction ≥ 50%
- Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab and/or any of the anti-cancer drug(s) given in combination with pertuzumab at the moment of the Parent study closure or that would put the patient at high risk for treatment-related complications.
- Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) in the time period between last treatment in the Parent study and the first dose pertuzumab in the extension study (i.e. up to 9 weeks)
- Positive serum pregnancy test
- Concurrent participation in any therapeutic clinical trial (other than the Parent study)
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety: Incidence of adverse events |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) |
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E.5.2 | Secondary end point(s) |
Efficacy: Progression-free survival; overall survival |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the last patient has completed their 7-month follow-up visit post-pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first) |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
safety and efficacy extension study |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | No |
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 | Yes |
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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The study will end after the last patient has completed their 7-month follow-up visit after their last dose of pertuzumab, unless all patients have withdrawn, have had disease progression, died, been lost to follow-up, or the study is terminated by the Sponsor (whichever occurs first). |
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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 | 10 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 10 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |