E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
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E.1.1.1 | Medical condition in easily understood language |
Cancer in the ovaries and organs related to the ovaries. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052171 |
E.1.2 | Term | Peritoneal carcinoma |
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016180 |
E.1.2 | Term | Fallopian tube 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 | 14.1 |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•To show non-inferiority of the experimental treatment and the control
treatment in terms of the change in AUC based treatment Cav of CA 125 relative to predose Cav of CA 125.
• To show non-inferiority of the experimental treatment and the control treatment in terms of progression free survival (PFS) using CT scans according to Response Criteria in Solid Tumors, RECIST, as assessed by central review.
• To show superiority of the experimental treatment over the control
treatment in terms of the incidence and severity of hypersensitivity
reactions. |
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E.2.2 | Secondary objectives of the trial |
• Response rate (RR) using CA125
• Overall response rate using CT scan
• ECOG performance score
• Safety and tolerability
• Pharmacokinetics of total and unbound paclitaxel and carboplatin in a
subset of patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
2. Patients relapsing > 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis.
3. CA 125 >2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non- measurable disease.
4. Age > 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance score 0-2
6. Life expectancy >12 weeks
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E.4 | Principal exclusion criteria |
1. Patient has peripheral neuropathy of grade ≥ 2 per NCI- CTCAE version 3.0
2. Surgical procedure due to progressive disease within 4 weeks of any of the CA- 125 measurements
3. Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1, Cycle 1).
4. Bowel obstruction at screening
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E.5 End points |
E.5.1 | Primary end point(s) |
• Change in AUC based treatment Cav of CA125 relative to predose Cav of CA125.
• Progression free survival (PFS) using CT scans according to Response Criteria in Solid Tumors,
• RECIST.
• Incidence and severity of hypersensitivity reactions.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
CA125 and PFS: During treatment and follow-up.
Hypersensitivity: During treatment |
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E.5.2 | Secondary end point(s) |
• Response rate (RR) using CA125
• Overall Response rate using CT scans
• ECOG performance score
• Safety and tolerability
• Concentration of total and unbound paclitaxel and carboplation, in a subset patients
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
RR, overal RR and ECOG: During treatment and follow-up.
Safety: During treatment and follow-up.
Concentration of paclitaxel and carboplation: During treatment and after administartion.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Evaluation of CA-125 and CT blinded |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Belarus |
Bulgaria |
Estonia |
Latvia |
Lithuania |
Russian Federation |
Ukraine |
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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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Until approximately 80% of the patients has progressed. Based on the estimated data needed to obtain statistical power. |
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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 | 4 |
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 | 4 |
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 |