이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

2022년 7월 7일 업데이트: Hoosier Cancer Research Network

Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

The purpose of this study is to determine whether BNC105P in combination with/following everolimus is effective in the treatment of progressive metastatic clear cell renal cell carcinoma following prior tyrosine kinase inhibitors.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

OUTLINE: This is a multi-center study.

Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle

  • Dose Level 1 Everolimus 10 mg BNC105P 4.2 mg/m2
  • Dose Level 2 Everolimus 10 mg BNC105P 8.4 mg/m2
  • Dose Level 3 Everolimus 10 mg BNC105P 12.6 mg/m2
  • Dose Level 4 Everolimus 10 mg BNC105P 16 mg/m2

Phase II: Patients will be randomized 1:1 to Arm A or Arm B

Combination Arm A: Everolimus 10 mg + BNC105P MTD (from Phase 1 study) 21 day cycle

Sequential Arm B: Everolimus 10 mg 21 day cycle

  • Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.

Karnofsky Performance Score (KPS) ≥70 within 7 days prior to registration for protocol therapy.

Life Expectancy: Not specified

Hematopoietic:

  • White blood cell count (WBC) > 3.5 K/mm3
  • Hemoglobin (Hgb) > 8.5 g/dL
  • Platelets > 100 K/mm3
  • Absolute neutrophil count (ANC) > 1.5 K/mm3

Hepatic:

  • Total Bilirubin < 1.25 x ULN
  • Aminotransferase (AST and ALT) < 2.5 x ULN

Renal:

  • Serum Creatinine < 2.5 x ULN (upper limit normal)

Cardiovascular:

  • No significant cardiovascular events within 6 months (CVA, CAD, peripheral arterial obstruction, arrhythmias, cardiac dysfunction) of registration for protocol therapy
  • No history of clinical CHF or LVEF <50% by Echo (or MUGA) within 30 days prior to registration for protocol therapy.

연구 유형

중재적

등록 (실제)

154

단계

  • 2 단계
  • 1단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alabama
      • Muscle Shoals, Alabama, 미국, 35661
        • Northwest Alabama Cancer Center
    • Arkansas
      • Hot Springs, Arkansas, 미국, 71913
        • Genesis Cancer Center
    • California
      • Burbank, California, 미국, 91505
        • Providence Health System: Roy and Patricia Disney Family Cancer Center
      • Corona, California, 미국, 92879
        • Compassionate Cancer Care Medical Group, Inc.
      • Corona, California, 미국, 92879
        • Compassionate Cancer Care Medical Group
      • Duarte, California, 미국, 91010
        • City of Hope
      • Fountain Valley, California, 미국, 92708
        • Robert A. Moss, M.D., FACP, Inc.
      • Fresno, California, 미국, 93720
        • California Cancer Associates for Research and Excellence
      • Greenbrae, California, 미국, 94904
        • Marin Specialty Care
      • Los Angeles, California, 미국, 90017
        • Good Samaritan Hospital
      • Los Angeles, California, 미국, 90095
        • UCLA Med - Hematology & Oncology
      • Riverside, California, 미국, 92501
        • Compassionate Cancer Care Medical Group
      • Whittier, California, 미국, 90603
        • American Institute of Research
    • Colorado
      • Denver, Colorado, 미국, 80210
        • Centura Health Research Center
      • Golden, Colorado, 미국, 80401
        • Western Oncology & Hematology
    • Florida
      • Brooksville, Florida, 미국, 34613
        • Cancer Care Centers of Florida: Brooksville
      • Fort Lauderdale, Florida, 미국, 33308
        • Broward Oncology Associates
      • Gainesville, Florida, 미국, 32610
        • University of Florida, Shands Cancer Center
      • Jacksonville, Florida, 미국, 32256
        • Cancer Specialists of North Florida
      • Miami, Florida, 미국, 33136
        • Advanced Pharma CR, LLC
      • New Port Richey, Florida, 미국, 34652
        • Cancer Care Centers of Florida
      • Ocala, Florida, 미국, 34471
        • Ocala Cancer Institute
      • Rockledge, Florida, 미국, 32955
        • Cancer Care Centers of Brevard
    • Georgia
      • Athens, Georgia, 미국, 30607
        • Northeast Georgia Cancer Care, LLC
      • Dublin, Georgia, 미국, 31021
        • Dublin Hematology & Oncology Care
    • Idaho
      • Post Falls, Idaho, 미국, 83854
        • Kootenai Cancer Center
    • Illinois
      • Chicago, Illinois, 미국, 60611
        • Northwestern University, Robert H. Lurie Comprehensive Cancer Center
      • Galesburg, Illinois, 미국, 61401
        • Medical & Surgical Specialists, LLC
      • Skokie, Illinois, 미국, 60076
        • Edward H. Kaplan, M.D., & Associates
    • Indiana
      • Evansville, Indiana, 미국, 47713
        • Deaconess Clinic
      • Fort Wayne, Indiana, 미국, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Goshen, Indiana, 미국, 46527
        • IU Health Goshen
      • Indianapolis, Indiana, 미국, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, 미국, 46219
        • IU Health Central Indiana Cancer Centers
      • Indianapolis, Indiana, 미국, 46256
        • Community Regional Cancer Center
      • Lafayette, Indiana, 미국, 47905
        • Horizon Oncology Research
      • Muncie, Indiana, 미국, 47303
        • IU Health at Ball Memorial Hospital Cancer Center
      • Munster, Indiana, 미국, 46321
        • Monroe Medical Associates
      • Newburgh, Indiana, 미국, 47630
        • Oncology Hematology Associates of SW Indiana
      • South Bend, Indiana, 미국, 46601
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Sioux City, Iowa, 미국, 51101
        • Siouxland Hematology Oncology Associates, LLP, Nylen Cancer Center
    • Kansas
      • Wichita, Kansas, 미국, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Hazard, Kentucky, 미국, 41701
        • Kentucky Cancer Clinic
      • Paducah, Kentucky, 미국, 42001
        • Purchase Cancer Group
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70809
        • Medical Oncology LLC
      • Metairie, Louisiana, 미국, 70006
        • Metairie Oncologists
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106
        • St. Joseph Mercy Hospital
      • Grand Rapids, Michigan, 미국, 49546
        • Cancer and Hematology Centers of Western Michigan
      • Wyoming, Michigan, 미국, 49519
        • Metro Health Cancer Care
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • Mayo Clinic
    • Montana
      • Bozeman, Montana, 미국, 59715
        • Bozeman Deaconness Cancer Center
      • Great Falls, Montana, 미국, 59405
        • Sletten Cancer Specialists
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Methodist Cancer Center
    • New Hampshire
      • Manchester, New Hampshire, 미국, 03102
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Elizabeth, New Jersey, 미국, 07202
        • Trinitas Regional Medical Center
      • Somerville, New Jersey, 미국, 08876
        • Somerset Hematology Oncology Associates
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87110
        • Presbyterian Medical Group
      • Albuquerque, New Mexico, 미국, 87131
        • University of New Mexico Cancer Center: Albuquerque
    • New York
      • Albany, New York, 미국, 12208
        • New York Oncology Hematology, PC
      • Buffalo, New York, 미국, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, 미국, 11042
        • NYU Langone Arena Oncology
      • New York, New York, 미국, 10029
        • Tisch Cancer Institute at Mount Sinai Medical Center
      • Nyack, New York, 미국, 10960
        • Hematology Oncology Associates of Rockland
    • North Carolina
      • Pinehurst, North Carolina, 미국, 28374
        • First Health of the Carolinas
    • Ohio
      • Middletown, Ohio, 미국, 45042
        • Signal Point Clinical Research Center
      • Wooster, Ohio, 미국, 44691
        • Lawrence M. Stallings, M.D.
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73120
        • Mercy Physicians Of Oklahoma
    • Oregon
      • Springfield, Oregon, 미국, 97477
        • Willamette Valley Cancer Institute
    • Pennsylvania
      • Danville, Pennsylvania, 미국, 17822
        • Geisinger Medical Center
      • Gettysburg, Pennsylvania, 미국, 17235
        • Gettysburg Cancer Center
      • Pittsburgh, Pennsylvania, 미국, 15212
        • Allegheny Cancer Center
      • State College, Pennsylvania, 미국, 16803
        • Mount Nittany Medical Center
      • West Reading, Pennsylvania, 미국, 19611
        • Berks Hematology Oncology Associates
    • Rhode Island
      • Cranston, Rhode Island, 미국, 02920
        • Hematology and Oncology Associates of Rhode Island
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • MUSC Hollings Cancer Center
      • Hilton Head Island, South Carolina, 미국, 29926
        • South Carolina Cancer Specialists
    • Tennessee
      • Germantown, Tennessee, 미국, 38138
        • The Jones Clinic, PC
    • Texas
      • Austin, Texas, 미국, 78758
        • Texas Oncology: Austin North
      • Bedford, Texas, 미국, 76022
        • Texas Oncology: Bedford
      • Dallas, Texas, 미국, 75246
        • Texas Oncology, PA
      • Fort Worth, Texas, 미국, 76104
        • Texas Oncology: Fort Worth
      • Houston, Texas, 미국, 77030
        • Methodist Hospital Research Institute
      • Houston, Texas, 미국, 77024
        • Texas Oncology: Houston Memorial City
      • Houston, Texas, 미국, 77055
        • Houston Cancer Center
      • Lubbock, Texas, 미국, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • San Antonio, Texas, 미국, 78229
        • CTRC at The UT Health Science Center at San Antonio
    • Virginia
      • Lynchburg, Virginia, 미국, 24501
        • Lynchburg Hematology Oncology Clinic, Inc.
    • Washington
      • Bremerton, Washington, 미국, 98310
        • Harrison HealthPartners Bremerton Hematology & Oncology
      • Kirkland, Washington, 미국, 98034
        • Cascade Cancer Center
      • Seattle, Washington, 미국, 98109
        • University of Washington, Seattle Cancer Care Alliance
      • Seattle, Washington, 미국, 98109
        • Group Health Medical Centers
      • Spokane, Washington, 미국, 99204
        • Rockwood Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • University of Wisconsin, Clinical Cancer Center
  • 싱가포르
      • Singapore, 싱가포르, 169610
        • National Cancer Centre Singapore
  • 호주
    • New South Wales
      • Camperdown, New South Wales, 호주, 2050
        • Royal Prince Alfred Hospital: Sydney Cancer Centre
      • Randwick, New South Wales, 호주, 2031
        • Prince of Wales Hospital
      • Wahroonga, New South Wales, 호주, 2076
        • Sydney Adventist Hospital Ltd.
    • Queensland
      • Greenslopes, Queensland, 호주, 4120
        • Gallipoli Medical Research Foundation: Greenslopes Private Hospital
      • Herston, Queensland, 호주, 4029
        • Royal Brisbane & Women's Hospital
      • Woolloongabba, Queensland, 호주, 4201
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, 호주, 5000
        • Royal Adelaide Hospital
      • Kurralta Park, South Australia, 호주, 5037
        • Ashford Cancer Centre
    • Tasmania
      • Launceston, Tasmania, 호주, 7250
        • Gallipoli Medical Research Foundation: Launceston General Hospital
    • Victoria
      • Frankston, Victoria, 호주, 3199
        • Peninsula Oncology Centre
      • Heidelberg, Victoria, 호주, 3084
        • Austin Hospital
      • Melbourne, Victoria, 호주, 3004
        • Alfred Hospital
    • Western Australia
      • Perth, Western Australia, 호주, 6000
        • Royal Perth Hospital

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 or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
  • Metastatic or locally advanced unresectable RCC. NOTE: Prior nephrectomy is not mandatory.
  • Progressive disease after 1-2 prior VEGF-directed tyrosine kinase inhibitors (TKIs).
  • Measurable disease according to RECIST and obtained by imaging within 30 days prior to registration for protocol therapy.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age > 18 years at the time of consent.
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.

Exclusion Criteria:

  • No active brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis within 30 days prior to registration on protocol therapy. NOTE: A patient with prior brain metastasis are eligible if they have completed their radiation treatment for brain metastasis ≥30 days prior to registration for protocol therapy, are off steroids, and are asymptomatic.
  • No other currently active malignancy.
  • No treatment with any investigational agent within 14 days prior to registration for protocol therapy. NOTE: If treated with investigational agent within 14 days prior to registration, AE must be resolved back to baseline.
  • Prior cancer treatment must be completed at least 14 days prior to registration for protocol therapy and the patient must have recovered from the acute toxic effects of the regimen. With the exception of Bevacizumab treatment, which must be completed 30 days prior to registration for protocol therapy.
  • Prior radiation therapy to < 25% of the bone marrow [see bone marrow radiation chart in the study procedure manual (SPM)] allowed if completed within 30 days prior to registration for protocol therapy.
  • Corrected QT interval (QTc) ≤ 450 msec at least 7 days prior to registration for protocol therapy.
  • No clinically significant infections as judged by the treating investigator.
  • No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis.
  • No collecting duct, medullary or sarcomatoid histology.
  • No prior treatment with temsirolimus or everolimus in the phase II component of the study. NOTE: Prior treatment with these agents is permitted in the phase I component of the study.
  • No use of full dose, therapeutic anti-coagulation with warfarin or related anti-coagulants or unfractionated or low molecular weight heparins.
  • No uncontrolled hypertension (BP >150/100mmHg despite full doses of 1 anti-hypertensive medication).
  • No thrombotic event within 6 months (deep vein thrombosis, pulmonary embolism) of registration for protocol therapy.
  • No grade 2 or greater peripheral neuropathy.

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: Combination Arm A: Everolimus + BNC105P
Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle
의약품: Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
의약품: BNC105P
BNC105P, up to 16 mg/m^2
활성 비교기: Sequential Arm B:Everolimus followed by BNC105P Monotherapy

Sequential Arm B: Everolimus 10 mg, 21 day cycle

Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.
의약품: Everolimus
Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals
의약품: BNC105P
BNC105P, up to 16 mg/m^2

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.
기간: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Phase I
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Phase I: Toxicities of BNC105P in Combination With Everolimus.
기간: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.
기간: 6 months
Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Phase I: Response Rate of BNC105P in Combination With Everolimus.
기간: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months
Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.
기간: 12 months
Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P
12 months
Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone
기간: 12 months
Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
12 months
Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.
기간: 12 months
Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
12 months
Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.
기간: 12 months
Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.
12 months
Phase II: Overall Survival
기간: 60 months
Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.
60 months
Exploratory Objective: Correlation of PFS With Biomarkers
기간: 6 months
Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoosier Cancer Research Network

협력자

Bionomics Limited

수사관

  • 연구 의자: Thomas Hutson, D.O., Hoosier Cancer Research Network

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

2010년 1월 1일

기본 완료 (실제)

2016년 12월 1일

연구 완료 (실제)

2016년 12월 1일

연구 등록 날짜

최초 제출

2009년 12월 15일

QC 기준을 충족하는 최초 제출

2009년 12월 15일

처음 게시됨 (추정)

2009년 12월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 7월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 7월 7일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HOG GU09-145

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. .

신장 세포 암종에 대한 임상 시험

Everolimus에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

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3
구독하다