NL-OMON43902已完成不适用
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations (CIDH305X2101) - Phase I study of IDH305 in advanced malignancies with IDH1R132 mutations
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
- 17
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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •* Subject must be *18 years of age
- •* Patients with advanced malignancies whose tumors harbor IDHR132 mutations and for whom there are no curative therapy options who have progressed despite standard treatment.
- •* Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained) for predictive and exploratory biomarker testing (eligibility will not be affected if a sample is not available or medically feasible to obtain).
- •* ECOG performance
- •* ECOG performance status * 2
- •* Measurable disease as per RECIST v1.1 (cholangiocarcinoma/other solid tumors), RANO criteria (glioma), IWG criteria (AML/MDS) in the dose expansion
排除标准
- •Exclusion Criteria for Patients with cholangiocarcinoma or other solid tumors and gliomas:
- •Patients eligible for this study must not meet any of the following criteria prior to the first treatment.
- •* Prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
- •* Major surgery within the 2 weeks preceding the first dose IDH305
- •* Patients who require medications that are narrow therapeutic index substrates of CYP3A, CYP2C9, CYP2C19, and CYP2C8 or strong inhibitors and strong inducers of CYP3A
- •* Rapidly progressing neurological symptoms related to underlying disease requiring increasing doses of corticosteroids. Steroid use for management of gliomas or brain metastases is allowed but the dose must be stable for at least 1 week preceding the baseline MRI/CT. If the corticosteroid dose is increased between the date of imaging and the initiation of study treatment, a new baseline MRI/CT is required.
- •* Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within the prior 2 years; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type
- •* Patients with corrected QT using the Fridericia correction (QTcF) > 470 msec, or other clinically significant, uncontrolled heart disease, including acute myocardial infarction or unstable angina < 3 months prior to the first dose of IDH305
- •* Any other medical condition that would, in the investigator*s judgment, prevent the patient*s participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease
- •* Patient*s with Gilbert*s syndrome or other heritable disorders of bile processing
- •* Patients with Acute Promyelocytic Leukemia
- •* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment
- •* Sexually active males must use a condom during intercourse while taking the drug and for 70 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
研究者
相似试验
进行中（未招募）
1 期
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 MutationsAdvanced Malignancies That Harbor IDHR132 MutationsNCT02381886Novartis Pharmaceuticals166
撤回
2 期
Phase 2 Study of IDH305 in Low Grade GliomasGliomaNCT02987010University of Texas Southwestern Medical Center
未知
3 期
A Phase III Study of IPD-1151T in Patients With Interstitial CystitisInterstitial cystitisJPRN-jRCT2080220253Taiho Pharmaceutical Co., Ltd.
进行中（未招募）
1 期
Ipilimumab, nivolumab and tocilizumab in pretreated patients with advanced pancreatic cancer.Pretreated patients with advanced pancreatic cancer.MedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10033607Term: Pancreatic cancer recurrentSystem Organ Class: 100000004864EUCTR2019-004438-40-DKDepartment of Oncology, Herlev & Gentofte Hospital30
撤回
2 期
Trial of IDH305 in IDH1 Mutant Grade II or III GliomaGliomaNCT02977689NYU Langone Health