EUCTR2020-004246-11-NL进行中（未招募）1 期
A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors - EDO-S101-1002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •Patient willing and able to sign the informed consent
- •Patients age =18 years at signing of the informed consent
- •Life expectancy > 3 months
- •Histologically confirmed diagnosis of advanced or metastatic solid
- •Patients with secondary metastasis to the central nervous system (CNS) are eligible if they have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to trial day 1 and they meet all of the following criteria: (1) Residual neurological symptoms = Grade 1 (2) No glucocorticoids requirement or patients may be receiving low doses of glucocorticoids providing the dose has been stable for at least 2 weeks prior to starting the trial medication (3) Follow-up imaging studies show no progression of treated lesions
- •and no new lesions
- •Evaluable disease; measurable on imaging as assessed by RECIST
- •version 1.1
- •ECOG performance status =2
- •ANC (polymorphonuclear [PMN] cells plus bands) >1,000/µL
- •Platelets =100,000/µL. . Platelet transfusions within the 14 days before
- •Day 1 of Cycle 1 is prohibited.
- •AST/ALT =3× upper limit of normal (ULN). In cases with liver involvement ALT/ AST =5× ULN
- •Total bilirubin =1.5 mg/dL unless elevated due to known Gilbert’s
- •Creatinine =1.5 ULN
- •Serum potassium and magnesium at least at the lowest limit of
- •normal (LLN) range, before every IMP administration. If it is below LLN, supplementation is permissible
- •Female study participants of child-bearing potential and their partners, and male study participants who intend to be sexually active with a woman of child-bearing potential, must be willing to use at least TWO highly effective forms of contraception
- •Histologically or cytologically confirmed limited or extensive disease
- •stage of SCLC
- •Received at least 1 line of prior combination chemotherapy or biological therapy and no other standard therapy with proven clinical benefit is available/recommended
- •At least 28 days should have elapsed since prior treatment as long as the patient has recovered from any related toxicities
- •Prior radiotherapy is acceptable the patient has recovered from any radiotherapy related acute toxicities
- •The disease progressing during/relapsing after the previous treatment
- •Presence of measurable disease as defined by RECIST version 1.1
- •Histologically confirmed diagnosis of advanced, unresectable, or
- •metastatic STS not amenable to curative treatment
- •Received at least 1 prior line chemotherapy or biological therapy regimen and no other standard therapy with proven clinical benefit is available or recommended. At least 28 days should have elapsed since prior chemotherapy as long as the patient recovered from any related
- •Disease progressing during or relapsing after the previous treatment
- •Presence of measurable disease as defined by RECIST version 1.1
- •RECRUITMENT INTO THIS COHORT HAS NOW BEEN HALTED
- •Histologically or cytologically confirmed advanced ovarian cancer
- •epithelial ovarian cancer including primary peritoneal cancer or fallopian tube cancer
- •At least 28 days should have elapsed since prior chemotherapy
- •Disease progressing during or relapsing after the previous treatment
- •Presence of measurable disease as defined by RECIST version 1.1
- •RECRUITMENT INTO THIS COHORT HAS NOW BEEN HALTED
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64
排除标准
- •Patients with primary CNS cancer
- •Patients with QTc interval (Fridericia’s formula) >450 ms
- •Patients who are on treatment with drugs known to prolong the QT/QTc interval
- •Patients who are being treated with Valproic Acid for any indication (epilepsy, mood disorder)
- •Any serious medical condition that interferes with adherence to trial procedures
- •Prior history of another solid tumor malignancy diagnosed within the last 3 years of trial enrollment excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer, in situ breast cancer, in situ prostate cancer (patients must have shown no evidence of active disease for 2 years prior to enrollment)
- •Pregnant or breastfeeding women
- •New York Heart Association (NYHA) stage III/IV congestive heart failure (Section 13.2). The following arrhythmias: atrial fibrillation/flutter with poor rate control, documented sustained ventricular tachycardia (defined as >30 seconds or requiring cardioversion before 30 seconds have elapsed) or TdP
- •Significant co-morbidities (e.g., active infection requiring systemic therapy, history of human immunodeficiency virus [HIV] infection, or active Hepatitis B or Hepatitis C)
- •Use of other investigational agents or previous anticancer therapies within 28 days prior to the first dose of tinostamustine, provided the patient has recovered from any related toxicities =Grade 1
- •Steroid treatment within 7 days prior to trial treatment. Patients that require intermittent use of bronchodilators, topical steroids, or local steroid injections will not be excluded from the trial. Patients who have been stabilized to 10 mg prednisolone orally (PO) once daily (QD) (or equivalent), daily (or less) at least 7 days prior to IMP administration are allowed
研究者
相似试验
进行中（未招募）
1 期
This study will evaluate the safety, efficacy and tolerability of Tinostamustine in Patients with Advanced Solid Tumors (abnormal clumps of cells which may occur in several places in the body). The study will be performed in multiple countries and hospitals.• Cohort 1: Relapsed/refractory Small Cell Lung Cancer• Cohort 2: Relapsed/refractory Soft Tissue Sarcoma• Cohort 3: Relapsed/refractory Triple-Negative Breast Cancer• Cohort 4: Relapsed/refractory ovarian cancer• Cohort 5: Relapsed/refractory endometrial cancerMedDRA version: 20.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10014735Term: Endometrial cancer NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10002479Term: Angiosarcoma NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10057043Term: DermatofibrosarcomaSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10015103Term: Epithelioid sarcoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10024193Term: Leiomyosarcoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10024631Term: Liposarcoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10042866Term: Synovial sarcoma NOSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10025556Term: Malignant fibrous histiocytoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10029276Term: Neurofibrosarcoma NOSSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10045154Term: Tumor of fibrous tissue NOSSystem Organ Class: 100000004864EUCTR2020-004246-11-ITMUNDIPHARMA RESEARCH LIMITED70
招募中
1 期
(VELA) Study of BLU-222 in Advanced Solid TumorsHR+ Breast CancerCCNE1 AmplificationHER2-negative Breast CancerAdvanced Solid TumorOvarian CancerEndometrial CancerGastric CancerMedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104CTIS2022-502528-29-00Blueprint Medicines Corp.366
招募中
2 期
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid LeukemiaAcute Myeloid Leukemia2024-516641-39-00Ab Science60
进行中（未招募）
1 期
A study evaluating the effects of navitoclax (ABT-263) in patients with relapsed or refractory chronic lymphocytic leukemia.Relapsed or Refractory Chronic Lymphocytic LeukemiaMedDRA version: 21.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractorySystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864EUCTR2007-002143-25-GBAbbVie Deutschland GmbH & Co. KG72
进行中（未招募）
不适用
A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia.Relapsed or Refractory Chronic Lymphocytic LeukemiaMedDRA version: 9.1Level: LLTClassification code 10008978Term: Chronic lymphocytic leukemia refractoryMedDRA version: 9.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaEUCTR2007-002143-25-DEAbbott GmbH & Co. KG72