Small Cell Lung Cancer MedDRA version: 14.1 Level: PT Classification code 10041071 Term: Small cell lung cancer stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: CABAZITAXEL
CAS Number: 183133-96-2
Current Sponsor code: XRP6258
Concentration unit: mg
Sponsors
Sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 103 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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);Primary end point(s): progression free survival ;Timepoint(s) of evaluation of this end point: up to 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: up to 24 months | — |
Countries
Brazil, Canada, Chile, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Norway, Poland, Romania, Russian Federation, Spain, Ukraine, United States
Outcome results
None listed