- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01531894
Continuation Study of the Oral AKT Inhibitor GSK2110183
2019년 6월 20일 업데이트: Novartis Pharmaceuticals
An Open Label Continuation Study of the Oral AKT Inhibitor GSK2110183 in Subjects With Solid Tumors and Hematologic Malignancies
This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK.
Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183.
Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study.
Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study.
Subjects were enrolled by cohort based on the duration and treatment received while in their parent study.
Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study.
Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.
연구 개요
연구 유형
중재적
등록 (실제)
11
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Seoul, 대한민국, 110-744
- Novartis Investigative Site
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Maryland
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Baltimore, Maryland, 미국, 21231
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Novartis Investigative Site
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New York
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New York, New York, 미국, 10029
- Novartis Investigative Site
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New York, New York, 미국, 10065
- Novartis Investigative Site
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Galway, 아일랜드
- Novartis Investigative Site
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Ontario
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Toronto, Ontario, 캐나다, M5G 1Z6
- Novartis Investigative Site
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Victoria
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Melbourne, Victoria, 호주, 3004
- Novartis Investigative Site
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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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Has provided signed informed consent for this study.
- Is currently participating in a GSK2110183 study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
- Currently benefitting from continued treatment and have an acceptable safety profile with GSK2110183 as determined by the investigator following previous treatment with GSK2110183 either as monotherapy or as part of a combination treatment regimen.
- Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- Male subjects with a female partner of childbearing potential must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 16 weeks after the last dose of GSK2110183.
- Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 weeks after the last dose of GSK2110183.
- Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
- Maintain a performance status score of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale
- Subjects with Type II diabetes are only allowed if their HbA1C is less than 8 percent at study entry.
- Have adequate organ system function
Exclusion Criteria:
- Permanent discontinuation of GSK2110183 in the parent study due to toxicity or disease progression.
- Concomitant use of any type of anti-cancer treatment other than studied in the parent protocol.
- Local access to commercially available GSK2110183.
- Current use of a prohibitive medication(s)
- Current use of anticoagulants
- Any unresolved toxicity greater than Grade 2 , except for alopecia, (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment at the time of transition to this study.
- History of HIV infection.
- Peripheral neuropathy greater than Grade 1
- History of hepatitis B or C infection (subjects with evidence of cleared hepatitis B are permitted).
- Evidence of severe or uncontrolled systemic diseases (e.g., unstable, or uncompensated respiratory, hepatic, renal, metabolic or cardiac disease).
- QTcF interval greater than 500 msecs at the time of transition to this study.
- Other clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
- Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study.
- Symptomatic or untreated leptomeningeal, CNS or brain metastases or spinal cord compression at the time of transition to this study.
- Lactating female or female who becomes pregnant prior to transition to this study.
- Previously diagnosed diabetes mellitus Type I. Subjects with Type II diabetes are allowed if entry criteria are fulfilled
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: GSK2110183 (afuresertib)
All patients received the GSK2110183 (afuresertib) treatment
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Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With at Least One Adverse Events (AEs)
기간: from the time of consent until the final study visit up to approx. 76 months
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Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
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from the time of consent until the final study visit up to approx. 76 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2012년 2월 8일
기본 완료 (실제)
2018년 6월 20일
연구 완료 (실제)
2018년 6월 20일
연구 등록 날짜
최초 제출
2012년 2월 9일
QC 기준을 충족하는 최초 제출
2012년 2월 9일
처음 게시됨 (추정)
2012년 2월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 7월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 20일
마지막으로 확인됨
2019년 6월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
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. .