E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Platinum refractory ovarian cancer |
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E.1.1.1 | Medical condition in easily understood language |
Ovarian cancer that does not respond to platinum-based chemotherapy |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033130 |
E.1.2 | Term | Ovarian cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 investigate the response rate of cabazitaxel in platinum refractory, ovarian cancer. |
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E.2.2 | Secondary objectives of the trial |
• To investigate the feasibility and safety of cabazitaxel treatment in ovarian cancer patients assessed by NCI CTCAE v.4.0.
• To investigate progression free survival (PFS), overall survival (OS), and toxicity.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
• Patients with refractory disease defined as progression or no change during primary treatment.
• Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
• Age ≥ 18 years.
• Performance stage 0-2.
• Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- Neutrophils (ANC) ≥ 1.5 * 10^9/l
- Platelet count ≥ 100 * 10^9/l
- Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/l
- Serum bilirubin ≤ 1.0 * ULN
- Serum transaminase ≤ 2.5 * ULN
- Serum creatinine ≤ 1.5 ULN. If creatinine 1.0 - 1.5 x ULN, chrom-EDTA clearence will be investigated. Patients with creatinin clearence < 40 mL/min should be excluded.
• Written informed consent.
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E.4 | Principal exclusion criteria |
• History of severe hypersensitivity reaction (≥grade 3) to taxol.
• History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week wash-out period is necessary for patients who are already on these treatments) (see Appendix).
• Neuropathy grade ≥ 2.
• Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
• Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
• Other malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
• Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
• CNS metastases not treated with radiotherapy.
• History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
• Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.
• Treatment with disulfiram (antabuse) |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Response rate according to RECIST 1.1 or GCIG criteria. |
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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) |
• Safety and feasibility
• Progression free survival (PFS)
• Overall survival (OS)
• Toxicity
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety, feasibility, and toxicity every 3 weeks
Progression free survival every 9 weeks
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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 | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Non-randomized, single arm, open trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
| 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 | 3 |
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 | No |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |