EUCTR2015-001111-12-DK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
Boehringer Ingelheim B.V.0 个研究点目标入组 204 人开始时间: 2021年1月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
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 advanced unresectable and/or metastatic, malignant solid tumour, which failed conventional treatment or with no therapy of proven efficacy, or not amenable to standard therapies
- •2.Age = adult legal age for the given country when signature of informed consent (ICF). For NC patients = 15 years when ICF (only adults in Germany and South Korea)
- •3.Oncology Group (ECOG) performance score 0 or 1 at the time of screening (up to 2 in NC)
- •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
- •6.both genders. Women of childbearing potential ready and able to use highly effective methods of birth control per ICH M3(R2)
- •7.Written ICF. For adolescent NC patients aged 15 to legal adult age, assent and ICF of the parents or legal guardian
- •8.Optional 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 NC
- •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 an EGFR inhibitor in RAS WT mCRC.
- •11.Have a measurable disease according to RECIST 1.1 (for NC 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 (not needed for NC patients) 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 NC 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 have:
- •1.Histologically or cytologically confirmed adenocarcinoma of the prostate.
- •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 bone scan plus a rising PSA as descr
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 including active infection with SARS-COV-2 confirmed by a PCR test or one in the prior 6 weeks 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 this trial
- •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 894999
- •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 case)
- •9.Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 times the upper limit of normal (ULN) (if liver metastases, >5 times ULN)
- •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 NC patients)
- •13.Treatment with other investigational drugs or participation in another interventional trial within the past 4 weeks (2 weeks for NC patients) 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 (2 weeks for NC patients) or 5 times the half-life of the drug, whichever is shorter. 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)
- •10.Platelets <100 x 109/L (without transfusions)
- •11.Serum creatinine > 1.5 mg/dL (132 µmol/L)
- •12.Significant concurrent medical disease or condition which according to the investigator’s judgement would either compromise patient safety or interfere with the evaluation of the safety
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