E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced metastatic ovarian cancer |
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MedDRA Classification |
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 determine the overall response rate (complete plus partial response) of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen. |
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E.2.2 | Secondary objectives of the trial |
To determine the quantitative and qualitative toxic effects of CT-2106 treatment. To estimate the response duration, time to progression, and survival.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subjects with histologically proven advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen; depending on the response to the prior platinum-taxane chemotherapy, patients will be classified as: • Platinum-refractory or platinum resistant patients (Group 1): patients with progressive or stable disease while on 1st line therapy. Patients presenting a response during the 1st line therapy but progressing while still on 1st line therapy will be considered as refractory (platinum-refractory). Patients who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval < 6 months; treatment-free interval is defined as: “time elapsing from the last day of 1st line therapy to the first day of second-line therapy start” (platinumresistant); • Platinum-sensitive patients (Group 2): Patients who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval ≥ 6 and ≤ 12 months; treatment-free interval is defined as: “time elapsing from the last day of 1st line therapy to the first day of second-line therapy start”
2. The patients must have recovered (≤ grade 1) from all side effects (except alopecia) of prior therapy (except for diarrhoea, which must be grade 0) 3. Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly 4. At least one measurable lesion according to RECIST 5. ≥18 years old 6. ECOG performance status ≤ 1 7. Life expectancy of more than 3 months as assessed by the investigator; 8. Adequate haematological function: Haemoglobin ≥ 10g/dl, ANC ≥ 2.0 × 109/L, platelets ≥ 100× 109/L 9. Adequate renal and hepatic functions: total bilirubin ≤ 1.25 x ULN, creatinine ≤ 1.25 ×ULN, ASAT and ALAT ≤ 2.5 × ULN, alkaline phosphatases ≤ 2.5 x ULN; in case of liver metastases, ASAT, ALAT and alkaline phosphatases must be ≤ 5 x ULN 10. Normal coagulation parameters (PT, aPTT, and INR) 11. Subjects must be willing and able to comply with scheduled visits and with management of toxicity 12. Patients with reproductive potential must be able to avoid a pregnancy during the whole study period 13. Signed informed consent prior to beginning protocol specific procedures
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E.4 | Principal exclusion criteria |
1. Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months; treatment-free interval is defined as: “time elapsing from the last day of 1st line therapy to the first day of second-line therapy start 2. Past or concurrent history of neoplasm other than ovarian adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix 3. Pregnant or lactating patients 4. More than one line of chemotherapy for advanced metastatic ovarian cancer 5. Prior treatment with camptothecins 6. Presence or history of CNS metastasis or carcinomatous leptomeningitis 7. Current active infection per investigator assessment 8. Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis 9. Current history of chronic diarrhea ≥ grade 1 (CTCAE version 3) 10. Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed 11. Other uncontrolled, serious illness or medical condition, as determined by the investigator 12. Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation 13. Concurrent treatment with any other anti-cancer therapy 14. Known HIV positivity or AIDS-related illness 15. Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the overall objective response rate (complete or partial responses). |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
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 | 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 | 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.8.3 |
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.8.5 | The trial involves multiple Member States | Yes |
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 |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 |