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Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

2012년 7월 2일 업데이트: Pfizer

A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer

The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

217

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 독일
      • Berlin, 독일, 10177
        • Pfizer Investigational Site
  • 미국
    • California
      • Corona, California, 미국, 92879
        • Pfizer Investigational Site
      • Fullerton, California, 미국, 92835
        • Pfizer Investigational Site
      • Glendora, California, 미국, 91741
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90095-1772
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90095-7423
        • Pfizer Investigational Site
      • Los Angeles, California, 미국, 90095
        • Pfizer Investigational Site
      • Mission Hills, California, 미국, 91345
        • Pfizer Investigational Site
      • Northridge, California, 미국, 91325
        • Pfizer Investigational Site
      • Palm Springs, California, 미국, 92262-4885
        • Pfizer Investigational Site
      • Pasadena, California, 미국, 91105
        • Pfizer Investigational Site
      • Pomona, California, 미국, 91767
        • Pfizer Investigational Site
      • Rancho Cucamonga, California, 미국, 91730
        • Pfizer Investigational Site
      • Santa Monica, California, 미국, 90404
        • Pfizer Investigational Site
      • Valencia, California, 미국, 91355
        • Pfizer Investigational Site
      • West Covina, California, 미국, 91790
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, 미국, 80010
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, 미국, 20010
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, 미국, 33428
        • Pfizer Investigational Site
      • Gainesville, Florida, 미국, 32605-4391
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국, 30341
        • Pfizer Investigational Site
      • Atlanta, Georgia, 미국, 30342
        • Pfizer Investigational Site
      • Decatur, Georgia, 미국, 30033
        • Pfizer Investigational Site
      • Macon, Georgia, 미국, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, 미국, 30060
        • Pfizer Investigational Site
      • Tucker, Georgia, 미국, 30084
        • Pfizer Investigational Site
    • Illinois
      • Zion, Illinois, 미국, 60099
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • Pfizer Investigational Site
    • Michigan
      • Bloomfield Hills, Michigan, 미국, 48302
        • Pfizer Investigational Site
      • Brownstown, Michigan, 미국, 48183
        • Pfizer Investigational Site
      • Dearborn, Michigan, 미국, 48126
        • Pfizer Investigational Site
      • Detroit, Michigan, 미국, 48202
        • Pfizer Investigational Site
      • West Bloomfield, Michigan, 미국, 48322
        • Pfizer Investigational Site
    • Mississippi
      • Biloxi, Mississippi, 미국, 39532
        • Pfizer Investigational Site
    • Missouri
      • Clarkson Valley, Missouri, 미국, 63011
        • Pfizer Investigational Site
      • St. Louis, Missouri, 미국, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, 미국, 63109
        • Pfizer Investigational Site
    • New Jersey
      • Midland Park, New Jersey, 미국, 07432
        • Pfizer Investigational Site
      • Morristown, New Jersey, 미국, 07962
        • Pfizer Investigational Site
      • Paramus, New Jersey, 미국, 07652
        • Pfizer Investigational Site
      • Pompton Plains, New Jersey, 미국, 07444
        • Pfizer Investigational Site
      • Ridgewood, New Jersey, 미국, 07450
        • Pfizer Investigational Site
      • Summit, New Jersey, 미국, 07902
        • Pfizer Investigational Site
      • Westwood, New Jersey, 미국, 07675
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, 미국, 10451
        • Pfizer Investigational Site
      • Bronx, New York, 미국, 10461
        • Pfizer Investigational Site
    • North Carolina
      • Clinton, North Carolina, 미국, 28388
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, 미국, 27534
        • Pfizer Investigational Site
      • Wilson, North Carolina, 미국, 27893
        • Pfizer Investigational Site
    • Oklahoma
      • Del City, Oklahoma, 미국, 73115
        • Pfizer Investigational Site
    • Pennsylvania
      • Greensburg, Pennsylvania, 미국, 15601
        • Pfizer Investigational Site
      • Hershey, Pennsylvania, 미국, 17033-0850
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, 미국, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, 미국, 15232-1305
        • Pfizer Investigational Site
      • Wexford, Pennsylvania, 미국, 15090
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, 미국, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, 미국, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, 미국, 38133
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, 미국, 75230-2510
        • Pfizer Investigational Site
      • Dallas, Texas, 미국, 75230
        • Pfizer Investigational Site
      • Fort Worth, Texas, 미국, 76177
        • Pfizer Investigational Site
      • Houston, Texas, 미국, 77024
        • Pfizer Investigational Site
      • Houston, Texas, 미국, 77055
        • Pfizer Investigational Site
      • Plano, Texas, 미국, 75093
        • Pfizer Investigational Site
      • Plano, Texas, 미국, 75075
        • Pfizer Investigational Site
      • Richardson, Texas, 미국, 75080
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78207
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, 미국, 78258
        • Pfizer Investigational Site
      • San Atonio, Texas, 미국, 78229
        • Pfizer Investigational Site
      • Tyler, Texas, 미국, 75702
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, 미국, 98003
        • Pfizer Investigational Site
      • Lakewood, Washington, 미국, 98499
        • Pfizer Investigational Site
      • Puyallup, Washington, 미국, 98372
        • Pfizer Investigational Site
      • Seattle, Washington, 미국, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, 미국, 98122
        • Pfizer Investigational Site
      • Tacoma, Washington, 미국, 98405
        • Pfizer Investigational Site
  • 불가리아
      • Sofia, 불가리아, 1233
        • Pfizer Investigational Site
      • Sofia, 불가리아, 1527
        • Pfizer Investigational Site
      • Sofia, 불가리아, 1756
        • Pfizer Investigational Site
      • Stara Zagora, 불가리아, 6000
        • Pfizer Investigational Site
      • Varna, 불가리아, 9000
        • Pfizer Investigational Site
  • 스페인
      • Barcelona, 스페인, 08035
        • Pfizer Investigational Site
      • Gerona, 스페인, 17007
        • Pfizer Investigational Site
      • Lleida, 스페인, 25198
        • Pfizer Investigational Site
      • Malaga, 스페인, 29010
        • Pfizer Investigational Site
      • Sevilla, 스페인, 41013
        • Pfizer Investigational Site
  • 영국
      • Edinburgh, 영국, EH4 2XU
        • Pfizer Investigational Site
      • Oxfordshire, 영국, OX3 7LJ
        • Pfizer Investigational Site
      • Southampton, 영국, SO16 6YD
        • Pfizer Investigational Site
  • 우크라이나
      • Dnipropetrovsk, 우크라이나, 49102
        • Pfizer Investigational Site
      • Kyiv, 우크라이나, 03115
        • Pfizer Investigational Site
      • Odessa, 우크라이나, 65055
        • Pfizer Investigational Site
  • 이탈리아
      • Aviano (PN), 이탈리아, 33081
        • Pfizer Investigational Site
      • Milano, 이탈리아, 20100
        • Pfizer Investigational Site
      • Prato, FI, 이탈리아, 59100
        • Pfizer Investigational Site
  • 체코 공화국
      • Brno, 체코 공화국, 656 91
        • Pfizer Investigational Site
      • Praha 8, 체코 공화국, 180 00
        • Pfizer Investigational Site
    • Ceska Republika
      • Brno, Ceska Republika, 체코 공화국, 656 91
        • Pfizer Investigational Site
      • Praha 8, Ceska Republika, 체코 공화국, 180 81
        • Pfizer Investigational Site
  • 칠면조
    • Balcali
      • Adana, Balcali, 칠면조, 01330
        • Pfizer Investigational Site
    • Besevler
      • Ankara, Besevler, 칠면조, 06510
        • Pfizer Investigational Site
    • Pendik
      • Istanbul, Pendik, 칠면조, 34890
        • Pfizer Investigational Site
    • Sihhiye
      • Ankara, Sihhiye, 칠면조, 06100
        • Pfizer Investigational Site
  • 캐나다
    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, 캐나다, M4N 3M5
        • Pfizer Investigational Site
  • 프랑스
      • BESANCON Cedex 5, 프랑스, 25052
        • Pfizer Investigational Site
      • BESANCON cedex, 프랑스, 25030
        • Pfizer Investigational Site
      • NANTES cedex, 프랑스, 44805
        • Pfizer Investigational Site
      • Paris Cedex 20, 프랑스, 75970
        • Pfizer Investigational Site
  • 헝가리
      • Budapest, 헝가리, 1082
        • Pfizer Investigational Site
      • Budapest, 헝가리, 1122
        • 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:

  • Recurrent or metastatic breast cancer
  • Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
  • Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
  • Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion Criteria:

  • More than two chemotherapy regimens for advanced disease
  • Uncontrolled/symptomatic spread of cancer to the brain

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
활성 비교기: 비
의약품: Chemotherapy

The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.

  1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
  2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
  3. Docetaxel - 75-100 mg/m2 every 3 weeks
  4. Paclitaxel - 175-200 mg/m2 every 3 weeks
  5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
  6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.
실험적: ㅏ
의약품: SU011248
SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
다른 이름들:
  • Sutent, sunitinib malate

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS)
기간: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of Participants With Objective Response
기간: Baseline until response or disease progression (up to 3 years from first dose)
Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.
Baseline until response or disease progression (up to 3 years from first dose)
Duration of Response (DR)
기간: Time from first response to disease progression up to 3 years from first dose
Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time from first response to disease progression up to 3 years from first dose
Survival Probability at 1 Year
기간: Baseline until death (up to 3 years after first dose of study medication)
Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.
Baseline until death (up to 3 years after first dose of study medication)
Overall Survival (OS)
기간: Baseline until death (up to 3 years after first dose of study medication)
Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline until death (up to 3 years after first dose of study medication)
Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
기간: Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
기간: Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
BR23: 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.
Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
기간: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of SU012662 (Metabolite of Sunitinib)
기간: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of Total Drug (Sunitinib + SU012662)
기간: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Sunitinib
기간: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
기간: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
기간: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
기간: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
기간: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
기간: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
기간: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
기간: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Circulating Endothelial Cells (CEC)
기간: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.
Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Circulating Tumor Cells (CTC)
기간: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs
Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal

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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

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 1월 1일

기본 완료 (실제)

2010년 5월 1일

연구 완료 (실제)

2011년 6월 1일

연구 등록 날짜

최초 제출

2005년 10월 27일

QC 기준을 충족하는 최초 제출

2005년 10월 27일

처음 게시됨 (추정)

2005년 10월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 7월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 7월 2일

마지막으로 확인됨

2012년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A6181077

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

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. .

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