A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
2016년 7월 13일 업데이트: Boehringer Ingelheim
The primary objective of this study is to estimate the Progression Free Survival Rates (PFS) of patients with relapsed ovarian cancer after 9 months of continuous treatment with either BIBF 1120 or matching placebo.
연구 개요
연구 유형
중재적
등록 (실제)
89
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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Burton on Trent, 영국
- 1199.9.4413 Boehringer Ingelheim Investigational Site
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Cambridge, 영국
- 1199.9.4412 Boehringer Ingelheim Investigational Site
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Creigiau, Cardiff, 영국
- 1199.9.4407 Boehringer Ingelheim Investigational Site
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Leeds, 영국
- 1199.9.4410 St James's University Hospital
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London, 영국
- 1199.9.4401 Boehringer Ingelheim Investigational Site
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London, 영국
- 1199.9.4404 Boehringer Ingelheim Investigational Site
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London, 영국
- 1199.9.4409 Boehringer Ingelheim Investigational Site
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London, 영국
- 1199.9.4411 Boehringer Ingelheim Investigational Site
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Manchester, 영국
- 1199.9.4406 Boehringer Ingelheim Investigational Site
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Northwood, 영국
- 1199.9.4402 Boehringer Ingelheim Investigational Site
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Sutton, 영국
- 1199.9.4405 Boehringer Ingelheim Investigational 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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Female patients with histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma or primary peritoneal cancer of serous type with recurrent disease and who responded to 2nd, 3rd or 4th line chemotherapy. Response is defined as either a confirmed decline in CA125 of at least 50% from the pre-treatment value or an Objective Response, i.e. a Partial Response (PR) or Complete Response (CR) according to the RECIST criteria in patients with measurable disease.
- Treatment-free interval of < 12 months since commencing prior treatment regimen for relapsed ovarian cancer.
- Full recovery from all therapy related toxicities of previous chemotherapy and or radiotherapy or recovery in as much as no further improvement may be expected by the investigator.
- Age > 18 years.
- Life expectancy of at least 3 months.
- ECOG Performance Score < 2.
- Adequate hepatic function: total bilirubin 26µmol/L, ALT and/or AST 1.5x upper limit of normal (ULN). INR, Prothrombin time (PT) and partial thromboplastin time (PTT): maximum 50% deviation from normal limits.
- Adequate renal function: serum creatinine 1.5 x ULN.
- Absolute neutrophil count (ANC) >1.5 x 109l, Platelets > 100 x 109/l, Haemoglobin > 9.0 g/dl.
- Written informed consent consistent with ICH-GCP guidelines.
- Minimum time elapsed since last chemotherapy (including hormonal treatment other than Hormone Replacement Therapy [HRT]) or immunotherapy and the first administration of BIBF 1120 must be more than 4 but less than 8 weeks.
Exclusion Criteria:
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
- Major injuries and/or surgery within past 4 weeks with incomplete wound healing or bone fracture and planned surgical procedures during the study period.
- Hypersensitivity to BIBF 1120 or the excipients of the study drug.
- Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II).
- History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
- Patients who require full-dose anticoagulation.
- Gastrointestinal disorders or abnormalities that would inhibit absorption of the study drug.
- Brain metastases or leptomeningeal disease.
- Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial.
- Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug.
- Patients unable to comply with the protocol.
- Active alcohol or drug abuse.
- Other documented malignancy with the exception of non-melanomatous skin cancer within the past 5 years.
- Patients who are not clinically sterile.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 중재 모델: 병렬 할당
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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실험적: BIBF1120
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PFS Rate at 36 Weeks (After 9 Months)
기간: 36 weeks (after 9 months)
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The rate (probability) of being progression free at Week 36.
Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up.
The rate is the Kaplan-Meier estimated percent probability.
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36 weeks (after 9 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
기간: 12 weeks (after 3 months) and 24 weeks ( after 6 months)
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The rate (probability) of being progression free at Week 12 and Week 24.
Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up.
The rate is the Kaplan-Meier estimated percent probability.
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12 weeks (after 3 months) and 24 weeks ( after 6 months)
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Time to Tumour Progression
기간: 9 months
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Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels. For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria: Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD. |
9 months
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Time to Death
기간: 9 months
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This end point was not determined as no patients died during the trial.
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9 months
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Incidence and Intensity of Adverse Events With Grading According CTCAE
기간: First drug administration until 28 days after last drug administration,up until 309 days
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Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
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First drug administration until 28 days after last drug administration,up until 309 days
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Clinical Relevant Abnormalities for Laboratory Parameters
기간: First drug administration until 28 days after last drug administration, up until 309 days
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Clinical Relevant Abnormalities for laboratory parameters.
Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
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First drug administration until 28 days after last drug administration, up until 309 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 3월 1일
기본 완료 (실제)
2008년 9월 1일
연구 완료 (실제)
2014년 3월 1일
연구 등록 날짜
최초 제출
2008년 7월 3일
QC 기준을 충족하는 최초 제출
2008년 7월 3일
처음 게시됨 (추정)
2008년 7월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 8월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 7월 13일
마지막으로 확인됨
2016년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1199.9
- EUDRACT2005-002427-14
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