EUCTR2016-004537-25-FR进行中（未招募）1 期
An Phase II trial aiming to evaluate the clinical interest of ABEMACICLIB monotherapy in patients with locally advanced/metastatic head and neck cancer after failure of platinum and cetuximab or anti-EGFR-based therapy and harboring an homozygous deletion of CDKN2A, and/or an amplification of CCND1 and/or of CDK6 - ABOR
Centre Léon Bérard0 个研究点目标入组 25 人开始时间: 2017年9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
- 25
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
- •INCLUSION CRITERIA
- •I1.Male or female patients aged = 18 years at time of inform consent signature.
- •I2.Histologically proven metastatic or locally advanced HNSCC (oropharynx, oral cavity, hypopharynx and larynx). Patients with cancer of nasopharynx (i.e. cavum cancer) are not eligible.
- •I3.Availability of a representative formalin-fixed paraffin-embedded (FFPE) primary and/or metastatic tumor tissue with an associated pathology report for molecular screening:
- •-Either an archival block
- •-Either a dedicated freshly collected tumor biopsy.
- •I4.Documented CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 amplification before C1D1.
- •Note: This molecular pre-screening will be centralized at the CGH platform of CLB using pre-treatment FFPE tumor sample.
- •Note: This molecular pre-screening can be performed for non-progressive patient but study drug treatment cannot be initiated until confirmed PD according to RECIST criteria..
- •I5.HPV negative tumor status must be documented before C1D1.
- •Note: This analysis will be centralized and performed by translational Biopathology platform of CLB during molecular screening by IHC with p16.
- •I6.Documented radiological progression or relapse after platin and cetuximab or anti-EGFR-based chemotherapy (combination or sequential treatment) at time of C1D1.
- •I7.At least one measurable lesion by CT-scan as per RECIST 1.1.
- •I8.At least one biopsiable tumor lesion at time of inclusion i.e. at least one lesion with a diameter of at least 10 mm, visible by medical imaging and accessible to percutaneous sampling.
- •I9.Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
- •I10.Life expectancy > 12 weeks.
- •I11.Patients must be able to swallow capsules.
- •I12.Adequate organ and bone marrow function as defined in the protocol
- •I13.Women of childbearing potential (entering the study after a confirmed menstrual period and who have a negative pregnancy test within 7 days before C1D1) must agree to use two methods of medically acceptable forms of contraception from the date of negative pregnancy test to 3 months after the last study drug intake.
- •I14.Fertile males must use a highly effective contraception during dosing period and through 3 months after final dose of study drug.
- •I15.Patient should be able and willing to comply with study visits and procedures as per protocol.
- •I16.Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
- •I17.Patients must be covered by a medical insurance.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •NI1.Cancer disease considered curable with surgery or radiotherapy.
- •NI2.Patient with a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
- •NI3.Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of abemaciclib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- •NI4.Patient has other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment contraindicate her participation in the clinical study (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis).
- •NI5.Persisting significant toxicities related to prior treatments i.e. = Grade 2 AE according to CTCAE V4.03 except alopecia (any grade) and biological values as defined in inclusion criteria.
- •NI6.Hypersensitivity to the active substance or excipient of study drug
- •NI7Have received prior treatment with any CDK4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded).
- •NI8.Patient has received treatment with a drug that has not received regulatory approval for any indication within:
- •-14 days of C1D1 for non myelosuppressive agent or
- •-21 days of C1D1 for a myelosuppressive agent.
- •NI9.Patient has had major surgery within 14 days prior to C1D1.
- •NI10.Patient has received within 28 days prior to C1D1 yellow fever vaccine
- •NI11.Patient has a personal history within the last 12 months prior to C1D1 of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- •NI12.Patient needs for the following concomitant medications/interventions not permitted during the study treatment period :
- •-Any investigational anticancer therapy other than the study drug.
- •-Any concurrent chemotherapy, radiotherapy (except palliative radiotherapy after discussion with the Sponsor), immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
- •-Major surgery.
- •-Strong and moderate inhibitors and inducers of CYP3A (for example Grapefruit juice, phenytoin and carbamazepine).
- •-Enzyme-Inducing Anti-Epileptic Drugs (EIAED).
- •NI13.Patient has received an autologous or allogeneic stem-cell transplant.
- •NI14.Patient has an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies).
- •NI15.Pregnant or breast-feeding female patients.
研究者
相似试验
进行中（未招募）
不适用
Phase II clinical trial to evaluate the efficacy and safety in the use of pancreatic islets cells from cadaver donors for the treatment of Type-I Diabetes Mellitus in renal transplant patients.Type-I Diabetes Mellitus in renal trasplant patientsMedDRA version: 8.1Level: ptClassification code 10061835EUCTR2005-004523-19-ESÁrea de Trasplante y Terapia Celular - Hospital Central de Asturias10
进行中（未招募）
1 期
Phase III clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19.COVID-19EUCTR2020-001760-29-ESSociedad Española de Farmacia Hospitalaria156
进行中（未招募）
1 期
APatients with HER2 positive disease.EUCTR2019-003702-27-FRAssistance Publique – Hôpitaux de Paris (AP-HP)12
进行中（未招募）
1 期
Evaluating the effect of Loratadine associated with Rapamune in Lymphagioleiomyomatosis (LAM).EFFECT OF LORATADINE ON LYMPHANGIOLEIOMYOMATOSISMedDRA version: 21.0Level: PTClassification code 10049459Term: LymphangioleiomyomatosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2020-000702-29-ESIDIBELL (Institut d’Investigació Biomédica de Bellvitge)62
进行中（未招募）
不适用
Clinical trial to determinate viral load in seminal fluid in HIV-positive patients without previous treatmentHIV-1 infectionMedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-001348-39-ESFundación pública andaluza para la gestión de la investigación en salud de Sevilla (FISEVI)