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Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

2011년 7월 20일 업데이트: Pfizer

A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

60

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alabama
      • Montgomery, Alabama, 미국, 36106
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, 미국, 19713
        • Pfizer Investigational Site
      • Newark, Delaware, 미국, 19718-6001
        • Pfizer Investigational Site
      • Wilmington, Delaware, 미국, 19899
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, 미국, 33308
        • Pfizer Investigational Site
    • Illinois
      • Harvey, Illinois, 미국, 60426
        • Pfizer Investigational Site
      • Tinley Park, Illinois, 미국, 60477
        • Pfizer Investigational Site
    • Indiana
      • Munster, Indiana, 미국, 46321
        • Pfizer Investigational Site
    • Louisiana
      • Lafayette, Louisiana, 미국, 70503
        • Pfizer Investigational Site
      • New Iberia, Louisiana, 미국, 70563
        • Pfizer Investigational Site
    • Mississippi
      • Corinth, Mississippi, 미국, 38834
        • Pfizer Investigational Site
      • Southaven, Mississippi, 미국, 38671
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, 미국, 89135
        • Pfizer Investigational Site
    • New York
      • New York, New York, 미국, 10021
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, 미국, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, 미국, 38120
        • Pfizer Investigational Site
  • 벨기에
      • Ottignies, 벨기에, 1340
        • Pfizer Investigational Site
      • Wilrijk, 벨기에, 2610
        • Pfizer Investigational Site
  • 스페인
      • Barcelona, 스페인, 08003
        • Pfizer Investigational Site
      • Madrid, 스페인, 28040
        • Pfizer Investigational Site
      • Valencia, 스페인, 46010
        • Pfizer Investigational Site
  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M4N 3M5
        • Pfizer Investigational Site
    • Quebec
      • Greenfield Park, Quebec, 캐나다, J4V 2H1
        • Pfizer Investigational Site
      • Montreal, Quebec, 캐나다, H3G 1A4
        • Pfizer Investigational Site
  • 프랑스
      • Besancon, 프랑스, 25030
        • Pfizer Investigational Site
      • Lyon, 프랑스, 69373
        • Pfizer Investigational Site
      • Saint Cloud, 프랑스, 92210
        • Pfizer Investigational Site

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:

  • A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
  • HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
  • Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

  • Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
  • Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
  • Prior treatment on a SU11248 clinical trial.
  • Uncontrolled brain metastases.

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: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ㅏ
의약품: SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Overall Confirmed Objective Disease Response
기간: From start of treatment through 18 months
Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.
From start of treatment through 18 months

2차 결과 측정

결과 측정
측정값 설명
기간
Duration of Response (DR)
기간: From start of treatment through 18 months
Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.
From start of treatment through 18 months
Percentage of Participants With Clinical Benefit
기간: From start of treatment through 18 months
Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.
From start of treatment through 18 months
Progression Free Survival (PFS)
기간: From start of treatment through 18 months
Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.
From start of treatment through 18 months
Time to Progression (TTP)
기간: From start of treatment through 18 months
Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.
From start of treatment through 18 months
Overall Survival (OS)
기간: From start of study treatment until death or 2 years from first study treatment
Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.
From start of study treatment until death or 2 years from first study treatment
Probability of Survival at One Year
기간: From start of study treatment until death or 2 years from first study treatment
One- year survival probability was estimated using the Kaplan-Meier method.
From start of study treatment until death or 2 years from first study treatment
EORTC QLQ-C30
기간: From start of treatment through 18 months
EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.
From start of treatment through 18 months
EORTC QLQ (BR23)
기간: From start of treatment through 18 months
BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
From start of treatment through 18 months
Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib
기간: Predose on Day 1 of Cycle 3 and 5
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
기간: Predose on Day 1 of Cycle 3 and 5
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Predose on Day 1 of Cycle 3 and 5
Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662)
기간: Predose on Day 1 of Cycle 3 and 5
Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.
Predose on Day 1 of Cycle 3 and 5

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

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

유용한 링크

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

2006년 2월 1일

기본 완료 (실제)

2009년 4월 1일

연구 완료 (실제)

2010년 7월 1일

연구 등록 날짜

최초 제출

2005년 10월 20일

QC 기준을 충족하는 최초 제출

2005년 10월 20일

처음 게시됨 (추정)

2005년 10월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 7월 20일

마지막으로 확인됨

2011년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A6181067

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. .

유방 신생물에 대한 임상 시험

SU011248/Trastuzumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Romania

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다