E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A phase I/II clinical study of CP4055 in patients with platinum resistant 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 |
Phase I: To determine the recommended dose of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12 (+2) q4W Phase II: To determine the antitumour activity of CP-4055 in patients with platinum resistant ovarian cancer according to Response Criteria in Solid Tumors RECIST and Gynecologic Cancet Intergroup (CGIG) CA-125 measurements |
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E.2.2 | Secondary objectives of the trial |
- Determine pharmacokinetic parameters - Explore the time to progression - Investigate the duration of tumor response - Determine the nature and degree of toxicity of CP-4055 in this patient population |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologically or cytologically documented advanced (stage III and IV according to the FIGO and AJCC systems) epithelial ovarian cancer measurable with CT and/or MRI, excluding mixed mullerian tumours (MMT) (carcinosarcomas) 2. Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT); i.e., carboplatin, cisplatin, or another organoplatinum compound. The last dose of prior chemotherapy should have been given at least 6 weeks before start of CP-4055 treatment 3. Evidence of platinum resistant or refractory disease. Resistant defined as progression according to RECIST or CA-125 within 6 months after completion of PBT. Refractory defined as progression during PBT or no disease free period during PBT. See Appendix B1 and Appendix B2 4. ECOG Performance Status 0 – 1 5. Age 18 years or more 6. Life expectancy > 3 months 7. Signed informed consent (IC) 8. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded. 9. Women of child-bearing potential must not become pregnant while participating in the study 10. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils ≥ 1.5 x 10 in 9 /L b. Platelets ≥ 100 x 10 in 9 /L c. Hb ≥ 9 g/dL • Hepatic function: a. AST (SGOT) / ALT (SGPT) ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases ≤ 5 times institutional ULN b. Serum bilirubin ≤ 1.5 times institutional ULN • Renal function: Creatinine ≤ 1.5 times institutional ULN
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E.4 | Principal exclusion criteria |
1. Patients with mixed mullerian tumours (MMT) (carcinosarcomas) 2. Known brain metastases 3. Another known active cancer within the last 5 years 4. Radiotherapy to more than 30 % of bone marrow 5. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study 6. Concomitant treatment with a non-permitted medication: • Alternative medicine, i.e., any of various systems of healing or treating disease (such as non-prescriptive drugs, herbal medicine, homeopathy) • High doses of vitamins 7. A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg 8. Any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection) 9. Any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 10. Pregnancy or breastfeeding 11. Known positive status for HIV and/or hepatitis B or C 12. Drug and/or alcohol abuse 13. Any reason why, in the investigator’s opinion, the patient should not participate
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the confirmed RR. The RR is defined either as PR and/or CR according to RECIST or as change in CA 125 level (at least a 50 % reduction in CA 125 levels from the pre-treatment sample). This RR will be estimated and a 95 % confidence interval calculated.
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
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 | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |