EUCTR2019-003727-38-IT进行中（未招募）1 期
OPEN-LABEL, MULTICENTRE, PHASE IB/II STUDY OF MEN1611, A PI3K INHIBITOR, AND CETUXIMAB IN PATIENTS WITH PIK3CA MUTATED METASTATIC COLORECTAL CANCER FAILING IRINOTECAN, OXALIPLATIN, 5-FU AND ANTI-EGFR CONTAINING REGIMENS - C-PRECISE-01
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
- •Patients meeting all the following criteria will be eligible for entry into the study:
- •1. Able to give written informed consent before any study related procedure.
- •2. Male and female patients aged = 18 years.
- •3. Histological documentation of adenocarcinoma of the colon or rectum with radiological evidence of progressive disease after last treatment received.
- •4. Progression or recurrence following prior irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens for metastatic disease. Patients who have a history of intolerance of irinotecan-based therapy or ineligibility to receive irinotecan are also eligible as long as they have received a prior oxaliplatin-based therapy. Patients who have a history of intolerance of oxaliplatin-based therapy or ineligibility to receive oxaliplatin are also eligible as long as
- •they have received a prior irinotecan-based therapy.
- •5. Best response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria to the last anti-EGFR containing regimen of partial response (PR) or at least stable disease (SD) for 4 months.
- •6. Measurable disease according to RECIST criteria, version 1.1.
- •7. N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutation detected in ctDNA assay during [pre]-screening period centrally analysed using a validated test.
- •8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •9. Life expectancy = 12 weeks.
- •10. Adequate cardiac function as defined by left ventricular ejection fraction of = 50% measured by a multigated acquisition (MUGA) scan or echocardiography (ECHO).
- •11. Adequate bone marrow function as defined by absolute neutrophil count (ANC) of = 1.5x 10^9/L, platelet count of = 100.0x 10^9/L and haemoglobin of = 9 g/dL.
- •12. Adequate liver function, as determined by total bilirubin within upper limit of normal (ULN) (= 1.5x ULN if documented liver involvement; = 3x ULN with direct bilirubin = 1.5x ULN in case of patients with coexisting known Gilbert’s disease) and/or AST and alanine aminotransferase (ALT) = 2.5x ULN (= 5x ULN if liver metastases).
- •13. Adequate renal function assessed by creatinine = 1.5x ULN.
- •14. Adequate electrolytes (serum potassium and magnesium levels within institutional normal limits). Replacement treatment to achieve adequate electrolytes is allowed.
- •15. Not pregnant, not breastfeeding, or at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP).
- •b) A WOCBP who agrees to use highly effective contraception 4 weeks before the first dose of the study treatment, during the treatment period and for 6 months following the last dose of the study treatment. Patients should not breastfeed during and at least for 6 months after the last dose of the study treatment.
- •16. Male patient who is surgically sterile or male patient who is willing to agree and have his female partners (if WOCBP) agreeing with the true abstinence (refrain from heterosexual intercourse) or who agrees to use and to have his female partners (if WOCBP) using barrier contraceptive measures during the entire study treatment period and for 6 months after the last administration of study drug, and agrees to refrain from donating sperm during the entire study treatment period and for 6 months after the last administration of study drug.
- •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 12
排除标准
- •Patients will not be eligible to participate in the study if they meet ANY of the following exclusion
- •1. Previous treatment with PI3K inhibitor.
- •2. Previous treatment with an anti-EGFR containing regimen for metastatic disease within 6 months prior to inclusion into the study.
- •3. Hypersensitivity and/or contraindication to MEN1611, cetuximab or to any component of the formulations.
- •4. Inability to swallow oral medications.
- •5. Untreated brain metastases, with the exception of patients with previously treated brain metastases (including radiation and/or surgery) > 4 weeks earlier and only if clinically stable (as determined by the Investigator) and not receiving corticosteroids.
- •6. NCI CTCAE v5.0 Grade = 2 diarrhoea, which is not resolved in the week prior to the start of any study treatment (Day 1 of Cycle 1, as applicable).
- •7. History of significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
- •a) Myocardial infarction within 6 months prior to the first dose of any study treatment (Day 1 of Cycle 1, as applicable).
- •b) Acute coronary syndromes (including unstable angina, coronary artery bypass grafting [CABG], coronary angioplasty or stenting) within 6 months prior to first dose of any study treatment (Day 1 of Cycle 1, as applicable).
- •c) Congestive heart failure (CHF) New York Heart Association Class III-IV.
- •d) Clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the Investigator.
- •e) Long QT syndrome or other risk factors for Torsades de Pointes” or increased QTc interval according to Fridericia formula (QTcF > 450 msec for males and QTcF > 460 msec for females).
- •f) Ventricular arrhythmia.
- •8. Symptomatic thromboembolic events or cerebrovascular accident including transient ischaemic attack within 6 months prior to the start of any study treatment (Day 1 of Cycle 1, as applicable).
- •9. Uncontrolled hypertension (defined as persistent BP of = 150/90 mmHg despite treatment, measured on at least 2 separate occasions).
- •10. Known active or uncontrolled pulmonary dysfunction.
- •11. Any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient’s safety.
- •12. Uncontrolled diabetes mellitus (HbA1c > 7%) and FPG > 126 mg/dL.
- •13. Known history of human immunodeficiency virus (HIV) infection or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).
- •14. Patients diagnosed with another primary malignancy, except for: adequately treated nonmelanoma skin cancer or cervical cancer in situ; or patients with another primary malignancy who are definitively relapse-free for at least 3 years since the diagnosis of the other primary malignancy.
- •15. Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.
- •16. Any chemotherapy, radiotherapy, immunotherapy, major surgery, biologic therapy or any other investigational agent within 30 days of the first administration of any study treatment.
- •17. Any other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- •18. Patient receiving treatment with drugs known to be strong inhibitors or inducers of isoenzyme CYP3A as well as strong inducers of CYP1A within 2 weeks of the first administration of MEN1611. Switching t
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