NL-OMON46915已完成不适用
A phase I, open label, multicenter, dose-escalation study of oral HDM201 in adult patients with advanced solid and hematological tumors characterized by wild-type TP53 - Phase I study of HDM201 in solid and hematological tumors (WT- P53)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- ECOG performance status 0-2
- •- Locally advanced or metastatic solid malignancy, that has progressed despite standardtherapy, or for which no effective standard therapy exists. Lymphomas are excluded.
- •- Refractory/relapse non-M3 AML ,
- •- High and very high risk MDS - IPSS-R (International Prognostic Scoring System ) score of > 4.5
- •- Acute Lymphoblastic Leukemia (B-ALL or T-ALL) including Ph+ ALL, or previously untreated patients who are considered inappropriate candidates for standard induction therapy
- •* Tumor of the patient is TP53wt (minimum no mutations in exons 5, 6, 7 and 8)
- •For solid tumor the TP53 status was obtained from a tumor sample collected no longer than 36 months before screening.
- •for hematologic tumors the TP53 status was obtained from a bone-marrow aspirate or extra medullary site, collected no longer than 3 months before screening.;* Tumor of the patient is TP53wt (minimum no mutations in exons 5, 6, 7 and 8):
- •For solid tumor the TP53 status was obtained from a tumor sample collected no longer than 36 months before screening except if HDM2 amplification is documented (irrespectively the date) or EBV positive gastric cancer. ;For hematologic tumors the TP53 status was obtained from a bone-marrow aspirate or extra medullary site, collected no longer than 3 months before screening.
排除标准
- •* Prior treatment with compounds with the same mode of action as proposed for HDM201,
- •* Symptomatic CNS metastasis (NB: Patients with CNS metastases are eligible for thisstudy only if they are asymptomatic, off corticosteroids, and radiographically stable for at least 2 months).
- •* Concurrent other malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix
- •* Patients with significant or uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment or heart attack within 12 months of starting study treatment
- •* History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism
- •* Diagnosis of acute or chronic pancreatitis
- •* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral HDM201
- •* Previous therapy that precludes enrollment < 2 weeks prior tostudy start: for details see protocol section 5.3 exclusion criteria #8.
- •Patients with hematological tumors
- •* WBC > 30 x109/L
- •* Platelets < 25 000/*L = 25 x 109 /L
- •* Hemoglobin < 8.0 g/dL = 4,96 mmol/L;Specific exclusion criteria for patients receiving eltrombopag
- •QTc <450msec or <480msec for patients with bundle branch block.
研究者
相似试验
已完成
不适用
A phase 1 multicenter, open label, dose-escalation study of oral LEE011 in patients with advanced solid tumors or lymphomas.cancerSolid tumors10027655NL-OMON39139ovartis20
已完成
不适用
A phase I, open-label, multi-center, dose escalation study of oral BGJ398, a pan FGF-R kinase inhibitor, in adult patients with advanced solid malignanciesAdvanced and/or metastatic cancer10027655NL-OMON45230ovartis13
终止
1 期
Intravenous APG-1387 administered to patients with advanced solid tumors and lymphomas to test for safety, tolerability and effect of APG-1387 on the body and how APG-1387 is processed by the human bodyadvanced solid tumorCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaCancer - Any cancerlymphomaACTRN12614000268640Jiangsu Ascentage Pharma Inc30
招募中
1 期
A Study of AZD0486 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin LymphomaB-Cell Non-Hodgkin LymphomaJPRN-jRCT2041230077Misaki Masako9
尚未招募
1 期
A Phase 1 Study of KK2269 Monotherapy and Combination Therapy with Docetaxel in Adult Participants with Solid Tumors-Part 1: locally advanced or metastatic solid tumors-Part 2: gastric/GEJ/ESO(adeno) or NSCLCJPRN-jRCT2031230419Masegi Chinatsu71