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Status:

COMPLETED

Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

Lead Sponsor:

Sanofi

Conditions:

Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Primary Objective: To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer follo...

Detailed Description

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment. All participants are to be followed for disease progression documentation and f...

Eligibility Criteria

Inclusion

  • Inclusion criteria :
  • Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
  • Male or female greater than or equal to (\>=) 18 years (or country's legal age of majority if greater than \[\>\]18 years)
  • Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 1
  • Exclusion criteria:
  • Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
  • More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
  • 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)
  • 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
  • Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
  • Participants with known leptomeningeal metastases
  • History of other, invasive neoplasm requiring ongoing therapy
  • Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
  • Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
  • Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
  • Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
  • Participant with reproductive potential (M/F) who did 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" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
  • History of hypersensitivity to polysorbate 80
  • Inadequate organ and bone marrow function as evidenced by:
  • Hemoglobin less than \[\<\] 9.0 gram per deciliter (g/dL)
  • Absolute neutrophil count \<1.5 x 10\^9 per liter
  • Platelet count \<100 x 10\^9 per liter
  • Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) \>2.5 x Upper Limit of Normal (ULN)
  • Alkaline Phosphatase (AP) \>2.5 x ULN. In case of liver metastases AP \>5 x ULN
  • Total bilirubin \>1.0 x ULN
  • Serum Creatinine \>1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance \<60 milliliter per minute (mL/min) was exclude the participant.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2014

    Estimated Enrollment :

    179 Patients enrolled

    Trial Details

    Trial ID

    NCT01500720

    Start Date

    March 1 2012

    End Date

    April 1 2014

    Last Update

    April 13 2015

    Active Locations (58)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 15 (58 locations)

    1

    Investigational Site Number 840007

    Muscle Shoals, Alabama, United States, 35661

    2

    Investigational Site Number 840005

    Omaha, Nebraska, United States, 68114

    3

    Investigational Site Number 840006

    Lebanon, New Hampshire, United States, 03756

    4

    Investigational Site Number 840003

    Middletown, Ohio, United States, 45042