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

2015년 3월 30일 업데이트: Sanofi

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

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)

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

179

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Athens, 그리스, 11522
        • Investigational Site Number 300005
      • Athens, 그리스, 11527
        • Investigational Site Number 300003
      • Heraklion, 그리스, 71110
        • Investigational Site Number 300001
      • Thessaloniki, 그리스, 54629
        • Investigational Site Number 300002
      • Thessaloniki, 그리스, 57010
        • Investigational Site Number 300004
  • 노르웨이
      • Oslo, 노르웨이, 0440
        • Investigational Site Number 578001
      • Stavanger, 노르웨이, 4011
        • Investigational Site Number 578003
      • Trondheim, 노르웨이, 7006
        • Investigational Site Number 578002
  • 대한민국
      • Seoul, 대한민국, 120-752
        • Investigational Site Number 410001
      • Seoul, 대한민국, 135-710
        • Investigational Site Number 410003
      • Seoul, 대한민국, 138-736
        • Investigational Site Number 410002
  • 독일
      • Großhansdorf, 독일, 22927
        • Investigational Site Number 276003
      • Löwenstein, 독일, 74245
        • Investigational Site Number 276006
  • 러시아 연방
      • Moscow, 러시아 연방, 115478
        • Investigational Site Number 643001
      • St-Petersburg, 러시아 연방, 197758
        • Investigational Site Number 643005
      • Tula, 러시아 연방, 300053
        • Investigational Site Number 643006
      • Yaroslavl, 러시아 연방, 150054
        • Investigational Site Number 643003
  • 루마니아
      • Cluj Napoca, 루마니아, 400015
        • Investigational Site Number 642003
      • Cluj-Napoca, 루마니아, 400015
        • Investigational Site Number 642005
      • Craiova, 루마니아, 200385
        • Investigational Site Number 642001
      • Timisoara, 루마니아
        • Investigational Site Number 642002
  • 미국
    • Alabama
      • Muscle Shoals, Alabama, 미국, 35661
        • Investigational Site Number 840007
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Investigational Site Number 840005
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • Investigational Site Number 840006
    • Ohio
      • Middletown, Ohio, 미국, 45042
        • Investigational Site Number 840003
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Investigational Site Number 840001
  • 브라질
      • Porto Alegre, 브라질, 90610-000
        • Investigational Site Number 076001
  • 스페인
      • Badalona, 스페인, 08916
        • Investigational Site Number 724002
      • Barcelona, 스페인, 08035
        • Investigational Site Number 724004
      • Málaga, 스페인, 29010
        • Investigational Site Number 724005
      • Valencia, 스페인, 46026
        • Investigational Site Number 724001
  • 우크라이나
      • Dnipropetrovsk, 우크라이나, 49102
        • Investigational Site Number 804002
      • Donetsk, 우크라이나, 83092
        • Investigational Site Number 804004
      • Lviv, 우크라이나, 70031
        • Investigational Site Number 804001
  • 이탈리아
      • Genova, 이탈리아, 16132
        • Investigational Site Number 380001
      • Livorno, 이탈리아, 57123
        • Investigational Site Number 380002
      • Novara, 이탈리아, 28100
        • Investigational Site Number 380005
      • Parma, 이탈리아, 43100
        • Investigational Site Number 380004
  • 칠레
      • Santiago, 칠레, 8380456
        • Investigational Site Number 152001
      • Santiago, 칠레
        • Investigational Site Number 152005
  • 캐나다
      • Montreal, 캐나다, H3T 1E2
        • Investigational Site Number 124003
      • Oshawa, 캐나다, L1G 2B9
        • Investigational Site Number 124002
      • Rimouski, 캐나다, G5L 5T1
        • Investigational Site Number 124004
      • Toronto, 캐나다, M5G 2M9
        • Investigational Site Number 124001
  • 폴란드
      • Gdansk, 폴란드, 80-952
        • Investigational Site Number 616004
      • Lublin, 폴란드, 20-954
        • Investigational Site Number 616003
      • Poznan, 폴란드, 60-569
        • Investigational Site Number 616002
      • Warszawa, 폴란드, 02-781
        • Investigational Site Number 616001
  • 프랑스
      • Brest, 프랑스, 29609
        • Investigational Site Number 250005
      • Caen Cedex, 프랑스, 14033
        • Investigational Site Number 250004
      • La Tronche, 프랑스, 38700
        • Investigational Site Number 250006
      • Lille, 프랑스, 59800
        • Investigational Site Number 250002
      • Saint-Herblain Cedex, 프랑스, 44805
        • Investigational Site Number 250003
      • Villejuif Cedex, 프랑스, 94805
        • Investigational Site Number 250007
  • 헝가리
      • Budapest, 헝가리, 1121
        • Investigational Site Number 348001
      • Budapest, 헝가리, 1121
        • Investigational Site Number 348004
      • Budapest, 헝가리, 1125
        • Investigational Site Number 348002
      • Törökbálint, 헝가리, 2045
        • Investigational Site Number 348003

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 카바지탁셀
의약품: Cabazitaxel
Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
다른 이름들:
  • XRP6258
활성 비교기: 토포테칸
의약품: Topotecan
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: From randomization to date of death (maximum 15 months)
Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
From randomization to date of death (maximum 15 months)
Progression Free Rate at Week 12
기간: Week 12
Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
Week 12
Overall Objective Tumor Response Rate
기간: Randomization to disease progression/occurrence (maximum 7.6 months)
Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
Randomization to disease progression/occurrence (maximum 7.6 months)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 3월 1일

기본 완료 (실제)

2014년 4월 1일

연구 완료 (실제)

2014년 4월 1일

연구 등록 날짜

최초 제출

2011년 12월 22일

QC 기준을 충족하는 최초 제출

2011년 12월 27일

처음 게시됨 (추정)

2011년 12월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 4월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 3월 30일

마지막으로 확인됨

2015년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ARD12166
  • 2011-003415-31 (EudraCT 번호)
  • U1111-1123-3503 (기타 식별자: UTN)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

소세포 폐암에 대한 임상 시험

Cabazitaxel에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Saint Lucia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다