Lung Cancer Clinical Trial

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

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 following a first line platinum based chemotherapy.

Secondary Objectives:

To assess disease progression free rate at 12 weeks
To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
To assess Overall Survival (OS)
To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
To assess the Health-Related Quality of Life (HRQoL)

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Full 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 for participant status until the study cut-off date.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

179

Study ID:

NCT01500720

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 54 Locations for this study

See Locations Near You

Investigational Site Number 840007
Muscle Shoals Alabama, 35661, United States
Investigational Site Number 840005
Omaha Nebraska, 68114, United States
Investigational Site Number 840006
Lebanon New Hampshire, 03756, United States
Investigational Site Number 840003
Middletown Ohio, 45042, United States
Investigational Site Number 840001
Philadelphia Pennsylvania, 19104, United States
Investigational Site Number 076001
Porto Alegre , 90610, Brazil
Investigational Site Number 124003
Montreal , H3T 1, Canada
Investigational Site Number 124002
Oshawa , L1G 2, Canada
Investigational Site Number 124004
Rimouski , G5L 5, Canada
Investigational Site Number 124001
Toronto , M5G 2, Canada
Investigational Site Number 152001
Santiago , 83804, Chile
Investigational Site Number 152005
Santiago , , Chile
Investigational Site Number 250005
Brest , 29609, France
Investigational Site Number 250004
Caen Cedex , 14033, France
Investigational Site Number 250006
La Tronche , 38700, France
Investigational Site Number 250002
Lille , 59800, France
Investigational Site Number 250003
Saint-Herblain Cedex , 44805, France
Investigational Site Number 250007
Villejuif Cedex , 94805, France
Investigational Site Number 276003
Großhansdorf , 22927, Germany
Investigational Site Number 276006
Löwenstein , 74245, Germany
Investigational Site Number 300005
Athens , 11522, Greece
Investigational Site Number 300003
Athens , 11527, Greece
Investigational Site Number 300001
Heraklion , 71110, Greece
Investigational Site Number 300002
Thessaloniki , 54629, Greece
Investigational Site Number 300004
Thessaloniki , 57010, Greece
Investigational Site Number 348001
Budapest , 1121, Hungary
Investigational Site Number 348004
Budapest , 1121, Hungary
Investigational Site Number 348002
Budapest , 1125, Hungary
Investigational Site Number 348003
Törökbálint , 2045, Hungary
Investigational Site Number 380001
Genova , 16132, Italy
Investigational Site Number 380002
Livorno , 57123, Italy
Investigational Site Number 380005
Novara , 28100, Italy
Investigational Site Number 380004
Parma , 43100, Italy
Investigational Site Number 410001
Seoul , 120-7, Korea, Republic of
Investigational Site Number 410003
Seoul , 135-7, Korea, Republic of
Investigational Site Number 410002
Seoul , 138-7, Korea, Republic of
Investigational Site Number 578001
Oslo , 0440, Norway
Investigational Site Number 578003
Stavanger , 4011, Norway
Investigational Site Number 578002
Trondheim , 7006, Norway
Investigational Site Number 616004
Gdansk , 80-95, Poland
Investigational Site Number 616003
Lublin , 20-95, Poland
Investigational Site Number 616002
Poznan , 60-56, Poland
Investigational Site Number 616001
Warszawa , 02-78, Poland
Investigational Site Number 642003
Cluj Napoca , 40001, Romania
Investigational Site Number 642005
Cluj-Napoca , 40001, Romania
Investigational Site Number 642001
Craiova , 20038, Romania
Investigational Site Number 642002
Timisoara , , Romania
Investigational Site Number 643001
Moscow , 11547, Russian Federation
Investigational Site Number 643005
St-Petersburg , 19775, Russian Federation
Investigational Site Number 643006
Tula , 30005, Russian Federation
Investigational Site Number 643003
Yaroslavl , 15005, Russian Federation
Investigational Site Number 724002
Badalona , 08916, Spain
Investigational Site Number 724004
Barcelona , 08035, Spain
Investigational Site Number 724005
Málaga , 29010, Spain
Investigational Site Number 724001
Valencia , 46026, Spain
Investigational Site Number 804002
Dnipropetrovsk , 49102, Ukraine
Investigational Site Number 804004
Donetsk , 83092, Ukraine
Investigational Site Number 804001
Lviv , 70031, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

179

Study ID:

NCT01500720

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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