EUCTR2017-001491-35-DE进行中（未招募）1 期
A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study withExpansion Arms to Assess the Safety, Tolerability, Pharmacokinetics andPreliminary Efficacy of CB-103 Administered Orally in Adult Patients withLocally Advanced or Metastatic Solid Tumours and HaematologicalMalignancies Characterised by Alterations of the NOTCH SignallingPathway
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •1. Disease
- •a. Histologically or cytologically confirmed solid tumours that are
- •surgically unresectable, locally advanced, or metastatic, which have
- •progressed on at least one line of systemic therapy (with the exception
- •of ACC patients who are allowed to be systemic treatment-naïve) and for
- •which no established therapeutic alternatives exist.
- •b. Relapsed or refractory (r/r) T-ALL or T-LBL. Refractory patients are
- •defined as T-ALL/T-LBL patients with = 5% bone marrow blasts, and/or concomitant extramedullary involvement, who have not
- •achieved a CR after standard induction/consolidation therapy attempt.
- •Relapsed patients are defined as T-ALL/T-LBL patients who have
- •recurrent disease, i.e. = 5% bone marrow blasts and/or
- •concomitant extramedullary relapse, after having achieved a prior CR.
- •[For all other disease related inclusion criteria refer to protocol]
- •2. Demography
- •a. Men and women = 18 years old on the day of signing informed
- •b. Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •c. Patients able and willing to swallow capsules.
- •3. Organ function and laboratory results
- •Patients must have the following laboratory values (obtained within 14
- •days of enrolment):
- •a. Total serum bilirubin = 1.5 x upper limit of normal (ULN)
- •b. Alkaline phosphatase (ALP) = 2.5 x ULN; if liver function
- •abnormalities are due to the underlying malignancy and known bone
- •metastases, then ALP must be = 5 x ULN
- •c. Serum aspartate aminotransferase (AST/SGOT) and alanine
- •aminotransferase (ALT/SGPT) = 2.5 x ULN; if liver function
- •abnormalities are due to the underlying malignancy and known hepatic
- •metastases, then AST and ALT must be = 5 x ULN
- •d. Serum creatinine = 1.5 x ULN; or if serum creatinine > 1.5 x ULN, then
- •serum creatinine clearance (CrCl) = 50 mL/min (estimated by Cockcroft-
- •Gault formula)
- •e. Potassium levels within normal limits or correctable with supplements
- •f. Total calcium levels (corrected for serum albumin) within normal limits
- •or correctable with supplements
- •g. Magnesium levels within normal limits or correctable with
- •supplements
- •h. Phosphorus levels within normal limits or correctable with
- •supplements
- •i. Serum albumin concentration = 30 g/L
- •j. Patients with solid tumours must have:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Haemoglobin (Hgb) = 10 g/dL (= 100 g/L)
- •Platelet count = 75 x 109/L (without platelet transfusion or growth
- •factor support in the preceding 7 days)
- •Partial thromboplastin time (PTT) = 1.5 x ULN and international
- •normalised ratio (INR) = 1.3 (unless the patient is receiving therapeutic
- •anticoagulants)
- •4. Contraceptive measures
- •a. Women of childbearing potential must have a serum pregnancy test
- •performed within a maximum of 7 days before start of study treatment,
- 另有 11 项未显示
排除标准
- •1.Medical History
- •a.Patients with symptomatic CNS metastases (neurologically unstable or requiring increasing doses of steroids to control their CNS disease)
- •b.Hypersensitivity to any of the excipients of CB-103
- •c.Patients with unresolved nausea, vomiting, or diarrhoea of CTCAE grade>1
- •d.Impairment of GI function or presence of GI disease that may significantly alter the absorption of CB-103
- •e.History of second or other primary cancer with the exception of
- •Curatively treated non-melanomatous skin cancer
- •Curatively treated cervical cancer or breast carcinoma in situ
- •Other primary solid tumour treated with curative intent and no known active disease present and no treatment administered during the last 2 years
- •2.Exclusionary concurrent medical conditions
- •a.Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
- •1.Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV),arrhythmia or conduction abnormality requiring medication, or cardiomyopathy
- •2.Clinically uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg)
- •3.Complete left bundle branch block
- •4.Right bundle branch block + left anterior hemiblock
- •5.Mandatory use of a cardiac pacemaker
- •6.Congenital long QT syndrome
- •7.History or presence of sustained or symptomatic ventricular
- •tachyarrhythmia
- •8.Presence of atrial fibrillation
- •9.Clinically significant resting bradycardia (<50 bpm)
- •10.Corrected QTcF > 450 ms for males and>470 ms for females at the screening ECG
- •11.QRS=110 ms
- •12.History of symptomatic congestive heart failure
- •13.LVEF<50%. History of absolute decrease in LVEF of=15 absolute %, or=10 absolute% and crossing from>LLN to14.Angina pectoris=6 months prior to starting CB-103
- •15.Acute myocardial infarction=6 months prior to startingCB-103
- •b.General conditions or other clinically significant diseases, including any one of the following:
- •1.Haemorrhagic, embolic, or thrombotic stroke within 6 months prior to the first planned CB-103 treatment
- •2.For patients with solid tumours: prior bone marrow/haematopoietic stem cell transplant
- •3.Known infection with HIV or hepatitis B or C requiring treatment
- •4.Any active infection requiring the use of parenteral anti-microbial agents or>Grade2
- •5.Non-malignant interstitial lung disease or pneumonitis
- •6.Dyspnoea of any cause requiring supplemental oxygen therapy and dyspnoea at rest due to complications of advanced malignancy and comorbidities
- •7.Significant traumatic injury or major surgery within 14d of scheduled dosing day 1
- •8.Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
- •3.Prior Therapy
- •a. In patients with solid tumours, cytotoxic chemotherapy within 3 weeks (6 weeks for nitrosoureas and mitomycin C) of the scheduled first dose of CB-103 on day 1.
- •b.In T-ALL/T-LBL patients, prior anti-cancer therapy less than 2 weeks prior to starting therapy or 5 half-lives (whichever is longer) with the following exceptions:
- •1. Up to 5 days of glucocorticoids (10 mg/m2 dexamethasone or equivalent/day) in combination with up to 3 doses of cyclophosphamide (200 mg/m2/day) are allowed as standard prephase treatment up to 1 day before start of study treatment
- •2. Mercaptopurine may be dosed up to 5 days prior to first dose of CB103
研究者
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