NCT01669798已完成2 期
Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
AA Secord3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Percentage of Patients Who Survive Progression-free
研究概览
简要总结
The main purpose of this study is to see if BIBF 1120 can increase the number of women with bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress for at least six months.
详细描述
Ovarian cancer patients with platinum-resistant and refractory disease have the lowest response rates to relapse chemotherapy: various chemotherapeutic agents, such as paclitaxel, liposomal doxorubicin, topotecan, docetaxel, platinum, etoposide, ifosfamide, gemcitabine, and vinorelbine are available but result in response rates of 7-40%. Unfortunately, relapse therapy is not curative and treatment is only palliative. Recently two phase II trials demonstrated that anti-angiogenic therapy with bevacizumab alone or in combination with chemotherapy in women with recurrent disease had response rates ranging from 16-24% with an acceptable toxicity profile. However, resistance can develop to VEGF inhibition. Therefore other novel anti-angiogenic agents, such as BIBF 1120, should be evaluated in the treatment of ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma w/ histologic documentation of the original primary tumor via the pathology report:
- •serious, endometrioid, mucinous, or clear cell adenocarcinoma
- •undifferentiated, mixed epithelial or transitional cell carcinoma
- •Brenner's Tumor
- •adenocarcinoma NOS
- •Had treatment-free interval following response to bevacizumab (CR, PR, or SD) of < 6 months, or have progressed during treatment w/ a bevacizumab-containing therapy
- •Measurable or detectable disease. Measurable is defined by RECIST 1.
- •Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI. Detectable defined as no measurable disease but either ascities/pleural effusion or solid/cystic abnormalities that don't meet RECIST 1.1 - both within the setting of CA125 >2xULN
- •Those with measurable disease must have at least one "target lesion" to assess response as defined by RECIST 1.
- •Tumors in a previously irradiated field will be designated as "non-target" lesions
- •Must have a ECOG Performance Status of 0 or 1
- •Free of active infection requiring antibiotics. Exception: uncomplicated UTI
- •Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- •Hormonal therapy directed at the malignant tumor must be d/c at least a week prior to registration. Hormone replacement therapy is permitted
- •Other prior therapy directed at malignant tumor, including immunologic agents, must be d/c at least 3 weeks prior to registration; 4 weeks if prior therapy was w/ bevacizumab
- •Prior therapy
- •must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
- •Allowed, to receive, but not required to receive, 2 additional cytotoxic regimens for management of recurrent or persistent disease according to the following:
- •Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy.
- •Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease other than bevacizumab. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen.
- •Must have adequate:
- •Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,500/mcl, equivalent to (CTCAE v4.0) grade
- •Platelets ≥ 100,000/mcl. Hemoglobin (Hb) ≥ 9.0 g/dL
- •Renal function: creatinine ≤ 1.5 x upper limit of normal (ULN)
- •Hepatic function: Bilirubin should be w/in normal limits (CTCAE v4.0, grade 1). ALT/AST, should be ≤ 1.5 x ULN (CTCAE v4.0, grade 1). For patients w/ liver metastases, ALT/AST should be ≤ 2.5 x ULN; Alkaline phosphatase should be ≤ 2.5 x ULN (CTCAE v4.0, grade 1)
- •Neurologic function: Neuropathy ≤ CTCAE v4.0, grade 1
- •Blood coagulation parameters: PT w/ international normalized ratio (INR) < 1.5 x ULN & a PTT < 1.5 x ULN (or an in-range PTT if on a stable dose of therapeutic heparin). Low molecular weight heparin (enoxaparin or alternative anticoagulants (other than warfarin)) are acceptable.
- •Signed informed consent & authorization permitting release of personal health information
- •Negative serum pregnancy test if of childbearing potential prior to study entry & use of effective form of contraception until 3 months after receiving last drug treatment
- •Patients may have undergone a major or minor surgical procedure as long as:
- •> 28 days prior to the first date of study therapy
- •Core biopsy or IV Port placement greater than 7 days prior to the first date of study therapy
排除标准
- •Previous treatment w/ BIBF
- •Pregnant or breastfeeding.
- •Received radiation to more than 25% of marrow-bearing areas
- •History of other invasive malignancies, w/ the exception of non-melanoma skin cancer, if there is any evidence of other malignancy being present w/in the last five years.
- •Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for treatment of ovarian, fallopian tube, or primary peritoneal cancer w/in the last 5 years.
- •Prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer or localized breast cancer w/in the last 5 years.
- •A history of abdominal or tracheal-esophageal fistula, or gastrointestinal perforation
- •A history of intra-abdominal abcess w/in 6 months of enrollment
- •Serious, uncontrolled, concomitant disorder(s) such as diabetes mellitus
- •Patients w/ clinically significant cardiovascular disease including: uncontrolled hypertension: systolic > 150 mm Hg/diastolic > 90 mm Hg; unstable angina or who have had a myocardial infarction w/in the past six months prior to registration; congestive heart failure; cardiac arrhythmia requiring medication (doesn't include asymptomatic atrial fibrillation); grade 2 or greater peripheral vascular disease (at least brief (<24 hours) episodes of ischemia managed non-surgically & w/o permanent deficit.
- •Serious non-healing wound, ulcer, or bone factor.
- •o Granulating incisions healing by secondary intention w/ no evidence of fascial dehiscence or infection ARE eligible but require weekly wound examinations.
- •Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
- •History/evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled w/ standard medical therapy, any brain metastases, CVA, TIA, or subarachnoid hemorrhage w/in 6 months of the first date of treatment on this study.
- •Central pulmonary metastases/recent hemoptysis (≥1/2 tsp of red blood) w/in 28 days of registration.
- •Clinically significant proteinuria (i.e. >Grade 1) or UPC ratio above 1.0
- •Suspicion of transmural tumor bowel involvement based on the investigator's discretion.
- •Clinical symptoms/signs of gastrointestinal obstruction & require IV hydration &/or nutrition.
- •Patients taking warfarin are not eligible
研究组 & 干预措施
BIBF 1120
Experimental
BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.
干预措施: BIBF 1120 (Drug)
结局指标
主要结局
Percentage of Patients Who Survive Progression-free
时间窗: 6 months
Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
次要结局
- Objective Tumor Response Based on GCIG CA-125 Criteria(1 year)
- Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1(1 year)
- Duration of Progression-Free Survival(Through study completion, on average 2 years)
- Adverse Event Frequency and Severity(1 year)
研究者
AA Secord
Associate Professor
Duke University
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Oral Treatment With BIBF 1120 ES in Advanced Non-small-cell Lung CancerCarcinoma, Non-Small-Cell LungNCT02182050Boehringer Ingelheim73
已完成
3 期
LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT00805194Boehringer Ingelheim1,314
已完成
2 期
Low Dose Cyclophosphamide +/-- Nintedanib in Advanced Ovarian CancerFallopian Tube CancerOvarian CancerNCT01610869University College, London117
终止
2 期
BIIB023 Proof-of-Concept Study in Participants With Lupus NephritisLupus NephritisNCT01499355Biogen276
已完成
1 期
A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120NeoplasmsNCT00715403Boehringer Ingelheim41