E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
EPITHELIAL OVARIAN CANCER
FALLOPIAN TUBE CARCINOMA
PRIMARY PERITONEAL CARCINOMA |
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E.1.1.1 | Medical condition in easily understood language |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052204 |
E.1.2 | Term | Ovarian carcinosarcoma |
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 | 15.0 |
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 | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian cancer |
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 assess the safety profile of bevacizumab when added to carboplatin and paclitaxel chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. |
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E.2.2 | Secondary objectives of the trial |
•To assess the efficacy of bevacizumab as measured by:
- progression-free survival
- overall response rate:
- by RECIST and 50% CA-125 response criteria (“responders”)
- by RECIST only (“RECIST responders”)
- by 50% CA-125 response criteria only (“CA-125 responders”)
- duration of response
- overall survival
- biological progression-free interval
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Collection of optional biomarker samples for Roche Clinical Repository (RCR) to assess non-inherted, genetic and tissue biomarkers:
Specimens taken for biomarker research will be used to:
• study early, intermediate and late escape mechanisms related to bevacizumab and chemotherapy regimen
• increase our knowledge and understanding of disease biology
• study the association of biomarkers with response and adverse reactions
• develop biomarker or diagnostic assays and to establish the performance characteristics of these assays
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E.3 | Principal inclusion criteria |
- Female patients, >/=18 years of age
- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Patients with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
- Life expectancy >/=3 months |
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E.4 | Principal exclusion criteria |
- Patients with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e. borderline tumors), or synchronous primary endometrial carcinoma
- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
- Planned intraperitoneal cytotoxic chemotherapy
- Radiotherapy within 28 days of Day 1, Cycle 1
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
- History or evidence of NCI CTCAE Grade ≥1 arterial thromboembolic event or Grade ≥3 venous thormboembolic event within the 6 months prior to enrolment |
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E.5 End points |
E.5.1 | Primary end point(s) |
safety endpoint:
- The primary variable is the incidence rate of adverse events and rates for selected events with incidences less than 1%
- The rate of adverse events is defined as the proportion of patients from the safety population that experienced at least one, or a specific AE.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Biological progression-free survival according to Response evaluation criteria in solid tumors (RECIST)
- Duration of response according to Response evaluation criteria in solid tumors (RECIST)
- Overall response rate according to Cancer antigen 125 criteria
- Overall response rate according to Response evaluation criteria in solid tumors (RECIST)
- Overall survival according to Response evaluation criteria in solid tumors (RECIST)
- Progression-free survival according to Response evaluation criteria in solid tumors (RECIST)</ |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
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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 | No |
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
| 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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 160 |
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 |
Argentina |
Austria |
Brazil |
Bulgaria |
Canada |
Denmark |
Egypt |
Estonia |
France |
Greece |
Hong Kong |
Hungary |
India |
Israel |
Italy |
Latvia |
Lithuania |
Macedonia, the former Yugoslav Republic of |
Mexico |
Netherlands |
Portugal |
Russian Federation |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
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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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End of study is defined as the date the last patient completes the 36th cycle of bevacizumab treatment. Patients will be followed (for survival and for progression-free survival) until 30 days after the last treatment cycle with bevacizumab in any patient. |
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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 |