EUCTR2019-000790-23-IT进行中（未招募）1 期
The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma - The BURAN Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 489
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
- •Aged =18yo.
- •Able to provide ICFobtained before any study related activities.
- •PT has histologically and/or cytologically-confirmed HNSCC.
- •Patient has archival or new tumor tissue for the analysis of
- •biomarkers. A tumor block (preferred) or a minimum of 12 (15
- •recommended) unstained slides to be provided. Enrollment in the study
- •is contingent on confirmation of an adequate amount of tumor tissue.
- •Patients progressing following treatment with an anti PD 1/anti PD L1 therapy are encouraged to have a new tumor biopsy for biomarker analysis.
- •PT has either progressive or recurrent disease after treatment with PDL1/PD1 based therapy for recurrent or metastatic disease:
- •PDLl/PD1 therapy alone for metastatic (monotherapy) disease
- •PDL1/PD1 in combination with chemotherapy for metastatic and
- •recurrent disease PDL1/PD1 used for metastatic disease, after or prior to receiving a
- •platinum agent for locally advanced or metastatic disease.
- •PT has received no more than two prior lines of systemic
- •treatment for HNSCC (single agent chemotherapy used as a
- •radiosensitizer is not counted as a prior line of therapy).
- •PT has measurable disease as determined per RECIST version 1.1.
- •If the only site of measurable disease is a previously irradiated lesion,
- •documented progression of disease and a four-week period since
- •radiotherapy completion is required.
- •PT has adequate bone marrow function and organ function as
- •shown by the following:
- •ANC=1.5x109/L.
- •Hemoglobin=9g/dL (which may be reached by transfusion).
- •Platelets=100x109/L (which may be reached by transfusion).
- •International normalized ratio (INR) = 1.5.
- •Ca(corrected for serum albumin) within normal limits (WNL) or
- •= grade 1 severity according to NCI-CTCAE version 5.0 if judged
- •clinically not significant by the Investigator. Patients concomitantly
- •taking bisphosphonates or denosumab for calcium correction are
- •AST and ALT=1.5 xULNor<3.0xULN if liver metastases
- •are present.
- •Total serum bilirubin = ULN or = 1.5 x ULN if liver metastases are
- •present; or total bilirubin = 3.0 x ULN with direct bilirubin below or
- •within normal range in patients with well documented Gilbert's
- •Syndrome. Gilbert's syndrome is defined as presence of episodes of
- •unconjugated hyperbilirubinemia with normal results from cells blood
- •count (including normal reticulocyte count and blood smear), normal
- •liver function test results, and absence of other contributing disease
- •processes at the time of diagnosis.
- •Serum creatinine = 1.5 x ULN or calculated or directly measured
- •creatinine clearance (CrCL) > 30 mL/min.
- •I. Haemoglobin A1c (glycosylated hemoglobin; HbA1c) =8%.
- •Patient has Eastern Cooperative Oncology Group (ECOG) performance
- •status =1.
- •Patient is able to swallow and retain oral medication. Patients able to
- •swallow oral medication but mostly self-nourished through gastric or
- •jejunal feeding tube are eligible.
- •Patients must apply highly effective contraception during and
- •throughout the study, as well after the final dose of study treatment, as
- 另有 9 项未显示
排除标准
- •Pt has received previous treatment with any PKB/AKT, mammalian target of rapamycin (mTOR) inhibitors, or PI3K pathway inhibitors.Pt received treatment with taxane as part prior treatment for
- •metastatic disease.
- •Pt has symptomatic CNS metastases.Pts with asymptomatic CNS metastases may participate in study. Pt must have
- •completed any prior local treat for CNS metastases=28 d prior to start study treatment (including radiotherapy) and must be on a stable low dose corticosteroid therapy. Radiosurgery must have been completed at least 14 d prior to start study treatment.
- •Pt has received wide field radiotherapy=4w or limited field
- •radiation for palliation=2 w prior to starting study treatment or
- •who have AE which have not recovered to grade1 or better
- •from previous chemotherapy treat.
- •Pt has grade=2 neuropathy, colitis, pneumonitis, elevated
- •HbA1C, and uncontrolled endocrinopathies from previous treatment.
- •Pt has had major surgery within 14 d prior to starting treatment or has not recovered from major side effects.
- •Pt is currently receiving increasing or chronic treatment (>5d) with corticosteroids or immunosuppressive agent. following uses of corticosteroids are permitted: single doses; standard premedication for paclitaxel, topical applications, inhaled
- •sprays, eye drops,local injections,or<10mg prednisolone or equivalent.
- •Pt is being treated start of study treatment with any of the following drugs:
- •Drugs known to be strong/moderate inhibitors or inducers of
- •isoenzyme cytochrome P4503A4(CYP3A4) including herbal
- •medications.Drugs with known risk inducing Torsades de Pointes.
- •Pt is currently receiving warfarin or coumarin-derived anticoagulant,prophylaxis, or otherwise. Therapy with heparin,LMWH,fondaparinux or NOACs is allowed.
- •Pt has a known hypersensitivity and/or contraindication to
- •paclitaxel, standard premedication for paclitaxel, or other products
- •containing Cremophor®.Pt has other concurrent severe and/or uncontrolled medical
- •conditions that would, in the Dr's judgment, contraindicatept participation
- •Pt has a known history of HIV infection.
- •Pt has any following cardiac abnormalities: Symptomatic congestive heart failure within 12 months
- •screening period ,History of documented congestive heart failure or
- •documented cardiomyopathy and LVEF<50% as determined by multiple gated acquisition (MUGA) scan orECHO, Myocardial infarction=6m prior to enrollment, Unstable
- •angina pectoris, Serious uncontrolled cardiac arrhythmia, Symptomatic
- •pericarditis, QT interval corrected according to the formula of Fridericia
- •(QTcF)>450 msec for males and 470 msec for females, on the
- •screening ECG, Currently receiving treatment with medication that has a
- •known risk to prolong the QT interval or inducing Torsades de Pointes,
- •and the treatment cannot be discontinued or switched to a different
- •medication prior to starting study treatment.
- •Pt has impairment of GI function or GI disease that may
- •significantly alter the absorption of study treatment.
- •Patient has a medically documented history of or active major
- •depressive episode, bipolar disorder (I or II), obsessive-compulsive
- •disorder, schizophrenia, a history of suicidal attempt or ideation, or
- •homicidal ideation or active severe personality disorders are not eligible.
- •Pt has other prior or concurrent malignancy except for the
- •following: adequately treated basal cell or squamous cell skin cancer, or
- •other adequately treated in situ cancer, early gastric or GI cancer
- •resected completely by endoscopy procedures
研究者
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