E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 investigate the efficacy of ZK 219477 in patients with recurrent ovarian cancer progressing during, or within 6 months of platinum-based chemotherapy (proof of concept) |
|
E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of ZK 219477 in this patient population
To assess the impact of the infusion duration on the tolerability of ZK 219477 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Females aged ≥18 years
2. Histologically proven cancer of any of the following types:
- Epithelial ovarian cancer - Peritoneal cavity cancer - Fallopian tube cancer
3. Suitability of response assessment by the following:
- Measurable disease according to modRECIST, or - CA-125 levels ≥ 2 times upper limit of normal (ULN) within 2 weeks prior to the first infusion
4. WHO performance status 0-1
5. Up to 2 previous chemotherapies; the most recent chemotherapy must have been a platinum-containing therapy
6. Progression of measurable disease or symptomatic relapse during or within 6 months of previous therapy (elevated CA-125 levels alone are insufficient for inclusion)
7. Time period since prior therapy:
- Prior radiotherapy: ≥ 4 weeks - Prior chemotherapy: ≥ 4 weeks - Prior immunotherapy: ≥ 3 weeks
8. Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
9. Adequate function of major organs and systems
- Nervous system: - No peripheral neuropathy ≥ Grade 2 - No altered mental status
- Hematopoietic: - Hemoglobin ≥ 9 g/dL - Absolute neutrophil count ≥ 1,500/mm3 - Platelet count ≥ 100,000/mm3
- Hepatic: - Bilrubin within normal range - AST/ALT ≤ 5 x ULN
- Renal: - Creatinine ≤ 1.5 x ULN
- Cardiovascular: - No symtomatic congestive heart failure - No unstable angina pectoris - No arrhythmia needing continuous treatment
- No other uncontrolled concurrent illness
10. Survival expectation ≥ 3 months
11. written informed consent |
|
E.4 | Principal exclusion criteria |
1. More than 2 previous chemotherapies
2. Prior treatment with epothilones
3. Use of any investigational drug within 4 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy
4. Previous radiation to the whole pelvis
5. Symptomatic brain metastases requiring whole-brain irradiation
6. Active infection
7. Any concomitant malignancy; the following exceptions are allowed;
- Non-melanoma skin cancer - Carcinoma in situ of the cervix - Malignancy with definitive treatment ≥ 5 years ago without relapse
8. Mixed mesodermal tumor (MMT)
9. Prior hormone therapy for any malignancy within 1 month
10. Childbearing potential
11. Any conditions that in the opinion of the investigator could affect the compliance with the study protocol |
|
E.5 End points |
E.5.1 | Primary end point(s) |
In patients with measurable disease:
- Proportion of patients with either CR or PR as best overall response
In patients without measurable disease:
- Proportion of patients with ≥ 50% reduction in CA-125 levels compared to the pretreatment sample |
|
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
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.8.5 | 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 | 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
|
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | |