CTRI/2011/07/001858Other1 期
A Phase 1, Open Label, Multicenter, Dose Escalating Cohort Study to Evaluate the Safety and Tolerability of Daily Oral Administration of P2745 in Patients with Relapsed/Refractory Hematologic Malignancies
Piramal Life Sciences Limited0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- Other
- 发起方
- 入组人数
- 100
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
入选标准
- •1.Male or female patients, of any race or ethnic group, of 18 years or more to less than 60 years of age.
- •2.Patients with a documented (histologically- or cytologically-proven), hematological malignancy that is relapsed or refractory to prior therapeutic regimens, and for whom no available standard therapeutic options that are anticipated to result in a durable remission.
- •3.Patients enrolled into DOSE ESCALATION COHORTS must have one of the following hematologic malignancies:
- •Relapsed/refractory leukemias by WHO classification, including ALL, AML, CLL, CML, CMML
- •Poor-risk myeoldysplastic syndrome (MDS) by WHO classification (i.e. RAEB-1 or RAEB-2)
- •Myelofibrosis (MF)
- •4.Patients enrolled into the MTD EXPANSION COHORT must have CML in chronic or accelerated (but not blast) phase, and meet all other eligibility criteria.
- •5.Patients with an ECOG performance status of less than 2, and an anticipated life expectancy of 3 months and more
- •6.Patients able to take oral tablets
- •7.Patients, male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 1 month after the last dose of study drug
- •8.Patients with the ability to understand and give written informed consent.
排除标准
- •1.Patients with inadequate recovery from toxicity associated with any prior antineoplastic therapy (generally less than Grade 1 will be considered eligible)
- •2.Patients with CNS (or leptomeningeal) involvement by their disease or symptoms suggesting CNS involvement
- •3.Women who are pregnant or lactating
- •4.Patients with any of the following serum chemistry abnormalities:
- •Total bilirubin higher than 1.5x the ULN unless considered due to Gilbert?s Syndrome
- •AST or ALT more than 3x the ULN (more than 5x ULN if due to leukemic hepatic involvement).
- •Serum creatinine more than 1.2x ULN (or a calculated creatinine clearance less than 60 mL/min/1.73 m2)
- •5.Patients with active, uncontrolled bleeding or with INR ULN for the institution
- •6.Patients with a significant cardiovascular disease or condition, including:
- •Uncontrolled congestive heart failure defined as NYHA Class II to IV
- •History of a clinically significant ventricular arrhythmia such as ventricular tachycardia, ventricular fibrillation, Torsades de pointes, or arrhythmias not controlled by medication,
- •Diagnosed or suspected congenital or acquired prolonged QT syndrome; history of prolonged QTc interval; prolonged QTc interval (more than 0.45 sec)
- •Unexplained syncope
- •Uncontrolled hypertension within 3 months of study entry
- •Symptomatic coronary heart disease (angina)
- •Myocardial infarction within 12 months of study entry
- •7.Patients with significant gastrointestinal (GI) abnormalities, including:
- •Prior surgical procedures affecting absorption; short bowel syndrome
- •Malabsorption, GI bleeding within 1 month of study entry
- •Vomiting or diarrhea of of more than 2 days duration within 2 weeks of study entry
- •8.Patients with treated or untreated graft versus host disease (GVHD) within 2 months of study entry
- •9.Patients with a history of allergic reactions attributable to compounds of similar chemical or biologic composition to P2745 (i.e., oxadiazole derivatives)
- •10.Patients with known seropositivity to HIV, known current acute or chronic Hepatitis B, known Hepatitis C (antigen positive), or hepatic cirrhosis
- •11.Patients with any other serious/active infection, or any infection requiring parenteral antibiotics
- •12.Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks of study entry
- •13.Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which would either compromise the patient?s safety or interfere with evaluation of the safety of the study drug
- •14.Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
- •15.Patients with the inability to comply with the protocol requirements
研究者
相似试验
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
进行中（未招募）
1 期
A safety and efficacy study in Children with Metachromatic Leukodystrophy recieving enzyme (HGT-1110) replacement by intrathecal injectioEUCTR2011-002044-28-DEShire Human Genetics Therapies Inc24
进行中（未招募）
1 期
A safety and efficacy study in Children with Metachromatic Leukodystrophy recieving enzyme (HGT-1110) replacement by intrathecal injectioEUCTR2011-002044-28-DKShire Human Genetics Therapies Inc24
已完成
不适用
A Phase I, multi-center, open label, dose escalation study of LEQ506, an oral Smoothened inhibitor, in patients with advanced solid tumorsSolid tumors / different types of advanced cancer10027655NL-OMON36627ovartis10
进行中（未招募）
1 期
A clinical trial to look at the safety and potential efficacy of FHD-609 in people with advanced synovial sarcomaAdvanced Synovial Sarcoma (SS)MedDRA version: 20.0Level: PTClassification code 10042863Term: Synovial sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001488-25-ESFoghorn Therapeutics Inc.70