A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment With BIBF 1120 Following Chemotherapy in Patients With Relapsed Ovarian Cancer
2016年7月13日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
89
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Burton on Trent、イギリス
- 1199.9.4413 Boehringer Ingelheim Investigational Site
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Cambridge、イギリス
- 1199.9.4412 Boehringer Ingelheim Investigational Site
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Creigiau, Cardiff、イギリス
- 1199.9.4407 Boehringer Ingelheim Investigational Site
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Leeds、イギリス
- 1199.9.4410 St James's University Hospital
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London、イギリス
- 1199.9.4401 Boehringer Ingelheim Investigational Site
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London、イギリス
- 1199.9.4404 Boehringer Ingelheim Investigational Site
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London、イギリス
- 1199.9.4409 Boehringer Ingelheim Investigational Site
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London、イギリス
- 1199.9.4411 Boehringer Ingelheim Investigational Site
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Manchester、イギリス
- 1199.9.4406 Boehringer Ingelheim Investigational Site
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Northwood、イギリス
- 1199.9.4402 Boehringer Ingelheim Investigational Site
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Sutton、イギリス
- 1199.9.4405 Boehringer Ingelheim Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 介入モデル：並列代入
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：プラセボ
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実験的：BIBF1120
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PFS Rate at 36 Weeks (After 9 Months)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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スポンサー
出版物と役立つリンク
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便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2006年3月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2014年3月1日
試験登録日
最初に提出
2008年7月3日
QC基準を満たした最初の提出物
2008年7月3日
最初の投稿 (見積もり)
2008年7月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年8月15日
QC基準を満たした最後の更新が送信されました
2016年7月13日
最終確認日
2016年7月1日
詳しくは
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