E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced, recurrent epithelial ovarian cancer
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033160 |
E.1.2 | Term | Ovarian epithelial cancer recurrent |
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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 |
(1) To determine the objective response rate of patients with advanced, recurrent epithelial ovarian cancer, cancer of the Fallopian tube or primary peritoneal adenocarcinoma treated with paclitaxel plus carboplatin and vorinostat using conventional RECIST criteria. |
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E.2.2 | Secondary objectives of the trial |
(1) To assess the safety, tolerability, and adverse experience profile of vorinostat administered in combination with paclitaxel plus carboplatin. (2) To determine the progression-free survival (PFS) of patients with advanced, recurrent epithelial ovarian cancer, cancer of the Fallopian tube or primary peritoneal adenocarcinoma treated with paclitaxel plus carboplatin and vorinostat.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histological verified epithelial carcinoma derived from ovarian, peritoneum or uterine tubes 2. Women ≥18 years old. 3. ECOG performance status ≤2 4. Expected duration of life >3 months. 5. Previous treatment regimen containing platinum and paclitaxel. 6. Platinum and paclitaxel sensitive tumor, defined as a minimum of 6 months from cessation of treatment until disease progression. 7. Measurable or assessable lesion. Patients having increased CA-125 as the only sign on recidive are also eligible. 8. Normal organ functions 9. Signed informed consent before inclusion. 10. Prepared to appear for the planned follow-up visits and capable of handling toxicity. |
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E.4 | Principal exclusion criteria |
1. Patients treated with an experimental drug within the last 4 weeks before inclusion, and patients who receive other concomitant anticancer treatment. 2. Patients having an active infection, or who have received intravenous antibacterial or antifungal medicine within the last 2 weeks before inclusion. 3. Patients previously treated with an HDAC inhibitor. Patients, who have been treated with Valproate for convulsions can be included, however only if the treatment has taken place > 30 days before inclusion. 4. Patients treated with steroid, who are not stabilized on a firm dose equivalent to a maximum of 10 mg prednisolone per day for the last 4 weeks before inclusion. 5. Previous treatment with more than 1st line chemotherapy. 6. Progression during 1st line treatment regimen containing platin/paclitaxel or disease progression less than 6 months after treatment cessation. 7. Concomitant serious and/or non-controllable medical condition such as noncontrollable infection (including HIV infected patients), hypertension, ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure. 8. Previous treatment for, or other concomitant malignant disease within the last 5 years, except for curative treated carcinoma in situ cervical cancer or basal cell carcinoma. 9. Previous serious allergic reactions such as anaphylactic shock. 10. Pregnancy or breast feeding (or women within the childbearing age who are not using recognized contraception during the treatment and at least 3 months after treatment cessation). 11. Peripheral neuropathy ≥ grade 2, unless this is due to a medical condition. 13. Patients with history of severe hyper sensitive reactions with regards to products containing Cremophor EL (cyclosporine or K-vitamin) and/or patients with known hypersensitivity towards compounds chemically connected to paclitaxel, carboplatin or vorinostat. 14. Clinical signs of cerebral metastases. |
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |