E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Platinresistent epithelial ovarie cancer eller primær peritoneal ovarie cancer |
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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 | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033160 |
E.1.2 | Term | Ovarian epithelial 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 |
• Progressionsfri overlevelse |
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E.2.2 | Secondary objectives of the trial |
• Total overlevelse.
• Responsrater.
• Tid til progression.
• Toxicitet.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inklusionskriterier
1. Histologisk bekræftet epithelial ovariecancer, primært tubae- eller primært peritoneal cancer. Stadie I-IV.
2. Carboplatinresistent ovariecancer tidligere behandlet med maximalt tre forskellige cytostatikaregimer (enkeltstof eller i kombination).
3. Alder ≥ 18 år.
4. Performancestatus 0-2.
5. Evaluerbar sygdom der kan vurderes ved CA125 GCIG kriterier (Gynaecologic Cancer Intergroup) eller RECIST (Response Evaluation Criteria in Solid Tumors) (Se appendix I+II)
6. Adækvat knoglemarvs-, lever- og nyrefunktion samt koagulationsparametre (indenfor syv dage inden behandlingsstart).
7. ANC ≥ 1,5*109
8. Trombocyttal ≥ 100*109/L
9. Hæmoglobin (Hb) ≥ 6 mmol/l
10. Se-bilirubin (BR) ≤ 1,5*ULN (Upper Limit of Normal)
11. Se-transaminase ≤ 2,5*ULN
12. Se-creatinin ≤ 1,5*ULN
13. Urinstix for protein ‹2+. (Såfremt stix viser protein ≥2+ skal der foretages døgnurinmåling hvor proteinindholdet skal være under 1 g.)
14. INR ≤1,5
15. APTT ≤ 1,5*ULN
16. Underskrevet informeret samtykke.
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E.4 | Principal exclusion criteria |
Eksklusionskriterier
1. Patienter som har modtaget anden form for eksperimentiel behandling eller har deltaget i et andet klinisk studie indenfor 28 dage før deltagelse i dette studie.
2. Gravide eller ammende. En negativ graviditetstest er obligatorisk hos fertile kvinder.
3. Fertile kvinder som ikke ønsker at bruge sikker contraception.
4. Ubehandlet tarmobstruktion eller massive gastrointestinale tumormasser konstateret ved CT scanning.
5. Andre aktuelle eller tidligere maligne sygdomme fraset kurativt behandlede non-melanom hudcancer eller andre typer cancer med minimal risiko for recidiv.
6. CNS-metastaser.
7. Underliggende medicinsk sygdom som ikke er adækvat behandlet (Diabetes, hjertekarsygdom).
8. Ukontrolleret hypertension (Vedvarende BT >150/100 til trods for antihypertensiv behandling).
9. Kirurgi inklusiv åben biopsi indenfor 4 uger før forventede første dosis Bevacizumab.
10. Patienter med ikke-helende sår eller frakturer.
11. Tidligere cerebrovaskulær attack (TVA), transient iskæmisk attack (TIA) eller subarachnoidalblødning (SAH) indenfor seks måneder.
12. Tromboemboliske eller hæmorragiske sygdomme i anamnesen.
13. Klinisk signifikant cardiovaskulær sygdom inkl.
-Myocardieinfarkt eller ustabil angina indenfor sidste 6 måneder inden behandlingsstart
-New York heart Association NYHA klasse ≥ 2
-Dårlig kontrolleret kardiel arytmi trods medicinsk behandling.
-Perifer vaskulær sygdom, grad 3 eller derover.
14. Aktuel eller tidligere (indenfor 10 dage inden behandlingsstart) kronisk brug af Aspirin > 325 mg daglig.
15. Aktuel eller nylig brug af fulddosis orale eller parenterale antikoagulantia eller trombolytiske medikamina.
16. Præeksisterende neuropati, sensorisk eller motorisk ≥ grad 2.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | 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) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |