E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | PT |
E.1.2 | Classification code | 10041071 |
E.1.2 | Term | Small cell lung cancer stage unspecified |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in patients with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy. |
|
E.2.2 | Secondary objectives of the trial |
o To assess disease progression free rate at 12 weeks
o To assess Response Rate (RECIST 1.1) and duration of response
o To assess Overall Survival (OS)
o To assess the Safety (NCI-CTC version 4.03)
o To assess the Health-Related Quality of Life (HRQoL) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
I 01. Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
I 02. Male or female ≥18 years (or country's legal age of majority if >18 years)
I 03. Patients with measurable disease, RECIST (version 1.1)
I 04. ECOG performance status ≤1 |
|
E.4 | Principal exclusion criteria |
E 01. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.
E 02. More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes.
E 03. Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization. (Radiotherapy for bone pain palliation is allowed).
E 04. Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 05. Uncontrolled CNS metastases: patients with CNS metastases may have previous irradiation, only patients with SD or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent can be included.
E 06. Patients with known leptomeningeal metastases
E 07. History of other, invasive neoplasm requiring ongoing therapy.
E 08. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
E 09. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
E 10. Any severe acute or chronic medical condition, which could impair the ability of the patient to participate in the study or interfere with interpretation of study results
E 11. Known HIV disease, or active hepatitis B or C (systematic testing is not required).
E 12. Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
E 13. Patient with reproductive potential (M/F) who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" will be based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation.
E 14. History of hypersensitivity to polysorbate 80
E 15. Inadequate organ and bone marrow function as evidenced by:
o Hemoglobin <9.0 g/dL
o Absolute neutrophil count <1.5 x 10 exp9/L
o Platelet count <100 x 10exp9/L
o AST/SGOT and/or ALT/SGPT >2.5 x ULN
o AP >2.5 x ULN. In case of liver metastases AP > 5 x ULN
o Total bilirubin >1.0 x ULN
o Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula, and creatinine clearance <60 mL/min will exclude the patient. |
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E.5 End points |
E.5.1 | Primary end point(s) |
progression free survival |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 | No |
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 |
Brazil |
Canada |
Chile |
France |
Germany |
Greece |
Hungary |
Italy |
Korea, Republic of |
Norway |
Poland |
Romania |
Russian Federation |
Ukraine |
United States |
|
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
| |
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |