EUCTR2015-001111-12-BE进行中（未招募）1 期
An open label, Phase Ia/Ib dose finding study with BI 894999 orally administered once a day in patients with advanced malignancies, with repeated administration in patients with clinical benefit - BI 894999 first in human dose finding study in advanced malignancies
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 158 人开始时间: 2015年5月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In patients with solid tumours
- •1.confirmed diagnosis of an advanced unresectable and/or metastatic,
- •malignant solid tumour, which failed conventional treatment or for
- •which no therapy of proven efficacy exists, or not amenable to standard
- •2.Age = 18 years when signature of the informed consent(ICF). For NMC patients = 15 years when ICF (for Germany only = 18)
- •3.Oncology Group (ECOG) performance score 0 or 1 at the time of
- •screening (2 allowed in NMC)
- •4.Recovery of therapy-related toxicities from previous chemotherapy,
- •tyrosine kinase inhibitors, hormone therapy, immunotherapy, antibodies,
- •vaccine therapy, or radiotherapy to CTCAE = grade 1 (except for
- •alopecia, peripheral sensory neuropathy grade 2)
- •5.Life expectancy = 12 weeks after the start of the treatment
- •6.Male or female patients. Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3(R2)
- •7.Written ICF. For adolescent NMC patients aged 15 to < 18 years assent and ICF of the parents or legal guardian
- •8.Optional written ICF for tumour biopsies in the escalation phase Ia In addition, all patients included in the expansion Phase Ib must:
- •9.Have one of the four diagnoses: SCLC, mCRPC, CRC or NMC
- •10.Have failed conventional treatments or who are not amenable to standard therapies (per criterion 1) that specifically include for:
- •a.SCLC: a platinum-based therapy, (previous treatment with topotecan is not mandatory)
- •b.mCRPC: a hormonal agent (abiraterone, enzalutamide, or apalutamide)
- •and a taxane (docetaxel or cabazitaxel)
- •c.CRC: fluoropyrimidine, oxaliplatin and irinotecan, bevacizumab when applicable and EGFR inhibitor in RAS WT mCRC
- •11.Have a measurable disease according to RECIST 1.1 (for NMC patients
- •non-measurable disease only is acceptable) or according to PCWG3 for
- •the mCRPC cohort (see point 5 below, specific to mCRPC patients)
- •12.Have progressive disease within the last 6 months, according to
- •RECIST 1.1 or according to PCWG3 (R17-3377) for the mCRPC cohort
- •(see point 5 below, specific to mCRPC patients)
- •13.Have a tumour lesion accessible for biopsies (pre- and at steady state
- •under treatment in Cycle 1, ideally from the same anatomic lesion)
- •(except for mCRPC patients having only bone metastases or patients with therapeutic INR). Biopsies are optional for NMC patients
- •14.Give written ICF for two tumour biopsies, one at screening and one
- •after start of treatment, between Day 8 and Day 11 of Cycle 1 (when
- •applicable)
- •In addition, all patients in the mCRPC expansion cohort of Phase Ib must
- •1.Histologically or cytologically confirmed adenocarcinoma of the
- •2.Radiographic evidence of metastatic prostate cancer (stage M1 or D2).
- •Distant metastases evaluable by bone scan, CT scan, or MRI within 28
- •days before the start of study treatment
- •3.PSA = 5 ng/mL (if no measurable disease by RECIST 1.1)
- •4.Prior surgical or chemical castration with a serum testosterone of <50
- •ng/dL (< 1.7 nmol/L) by luteinizing hormone releasing level hormone
- •(LHRH) agonist or antagonist or by abiraterone or by enzalutamide or
- •apalutamide. If the actual method of castration is LHRH agonist or
- •antagonist, the patient must be willing to continue its use during
- •protocol treatment
- •5.Progressive disease defined as at least one of the following:
- •a.Progressive measurable disease: using conventional solid tumour
- •criteria RECIST 1.1
- •b.Bone scan progression: at least two new lesions on bo
排除标准
- •In patients with solid tumours
- •1.Inability to swallow tablets
- •2.Additional other serious illness , concomitant disease (e.g. active
- •infectious disease or active Hepatitis B with positive Hep B DNA test,
- •active Hep C infection with positive Hep C RNA test and HIV infection
- •(positive result in established HIV diagnosis assay), or ongoing toxicity
- •from prior therapies with the potential to compromise patient's safety in
- •3.History or presence of cardiovascular abnormalities deemed clinically
- •relevant by the investigator such as uncontrolled hypertension,
- •congestive heart failure NYHA classification of 3, unstable angina or
- •poorly controlled arrhythmia. Myocardial infarction within 6 months prior
- •to study entry. LVEF less than 50% at baseline.
- •4.Clinical evidence of symptomatic progressive brain or leptomeningeal
- •disease during the last 28 days before the start of treatment with BI
- •5.Second malignancy requiring another anti-cancer therapy
- •6.Absolute neutrophil count <1500/mm3
- •7.Platelet count <100 000/mm3
- •8.Bilirubin>1.5 mg/dL (>26 µmol/L, SI unit equivalent) (except known
- •Gilbert's syndrome (accepted up to 2 mg/dL or up to 34.2 µmol/L in this
- •9.Aspartate amino transferase (AST) and/or alanine amino transferase
- •(ALT) >2.5 times the upper limit of normal (ULN) (if liver metastases, >5
- •10.Serum creatinine >1.5 mg/dL (>132 µmol/L, SI unit equivalent)
- •11.Women who are breastfeeding, pregnant or who plan to become
- •pregnant during trial
- •12.Previous treatment with a BET inhibitor (allowed only for NMC
- •13.Treatment with other investigational drugs or participation in another
- •interventional trial within the past 4 weeks or within 5 times the half-life
- •of the previous investigational drug, whichever is the shorter, before
- •start of therapy or concomitant with this trial
- •14.Systemic anti-cancer therapy within 4 weeks or 5 times the half-life
- •of the drug, whichever is shorter (for NMC patients, washout for
- •monoclonal antibodies must be discussed with the sponsor).
- •Radiotherapy given for curative intent within the past 4 weeks before
- •start of therapy or concomitantly with this trial. These restrictions do not
- •apply to LHRH agonists or antagonists, steroids (given at a stable dose
- •in the last 4 weeks) used for palliative intent , bisphosphonates,
- •denosumab and to palliative radiotherapy (no wash out required)
- •15.Patients unable to comply with the protocol
- •16.Patients who are actively abusing alcohol or drugs (judgement of
- •abuse at investigator's discretion)
- •In patients with DLBCL
- •1.Patient is eligible for curative salvage high dose therapy followed by stem cell transplant.
- •2.Primary central nervous system (CNS) lymphoma or known CNS involvement
- •3.Prior allogeneic bone marrow or stem cell transplant
- •4.Second malignancy currently requiring another anti-cancer therapy
- •5.High-dose therapy with stem cell support <3 months prior to visit 1
- •6.Inability to swallow tablets
- •7.AST or ALT >2.5 x upper limit of normal (CTCAE grade 2 or higher)
- •8.Total bilirubin >1.5 x upper limit of normal (CTCAE grade 2 or higher)
- •9.Absolute neutrophil count <1.0 x 109/L (without growth factor support)
- 另有 3 项未显示
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