Track topics on Twitter Track topics that are important to you
This is a single-arm, open label phase I/II clinical trial studying the combination of oral imatinib 400 mg, once daily, and oral selinexor given once weekly. The study will consist of an initial escalation phase evaluating increasing doses of selinexor in combination with fixed doses of imatinib administered in repeated 28-day cycles in advanced/metastatic, TKI-refractory GIST patients, followed by an expansion phase testing for safety and preliminary evidence of antitumor activity.
Clinical Study Objectives:
Primary clinical study objective
1.- To determine the maximum tolerated dose (MTD) and recommended phase II doses (RP2D) of selinexor in combination with imatinib among unresectable and/or metastatic GIST patients with prior failure to at least imatinib for advanced/metastatic disease. Secondary clinical study objectives
1. - To evaluate the clinical benefit rate (CBR: CR+PR+ SD ≥ 16 wks).
2. - To evaluate progression free survival (PFS).
3. - To evaluate overall survival (OS).
4. - To evaluate the objective response rate (ORR).
5. - To evaluate the safety profile according to CTCAE 4.03.
6. - To compare PFS on selinexor and imatinib with PFS on last prior anti-cancer therapy.
Translational Study Objective:1.- To explore the relationship between GIST genotype and CBR with selinexor and imatinib.
Pharmacokinetics Study Objective: 1.- To measure the plasma concentration of imatinib and selinexor at limited timepoints specificed in schedule of assessment.
Maximum Tolerated Dose
Hospital Virgen del Rocio
Grupo Espanol de Investigacion en Sarcomas
Published on BioPortfolio: 2019-10-29T14:36:39-0400
This protocol corresponds to a multicenter, open-label, non-randomized, phase I study designed to determine the safety of the combination of selinexor with chemotherapy in young patients w...
This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's ...
The main purpose of this study is to establish a safe and tolerable dose combination (the "maximum tolerated dose") of selinexor and ixazomib when used together for the treatment of patien...
The main purpose of this study is to determine the safety of combining selinexor with daunorubicin and cytarabine. The maximal tolerated dose (MTD) of selinexor with daunorubicin and cytar...
This is an open-label, randomized clinical study with two stages to assess the maximum tolerated dose (MTD), efficacy, and safety of selinexor, lenalidomide, and dexamethasone (SLd) in pat...
Imatinib has favorable pharmacokinetic properties, but primary and secondary resistance mechanisms may cause a decrease in clinical response over time. There is a positive correlation between serum im...
In oncology, the aim of dose-finding phase I studies is to find the maximum tolerated dose for further studies. The use of combinations of two or more agents is increasing. Several dose-finding design...
Volasertib induces mitotic arrest and apoptosis by targeting Polo-like kinases. In this phase I dose-escalation study, the maximum tolerated dose (MTD), pharmacokinetics (PK), and preliminary efficacy...
Capmatinib is an oral, ATP-competitive, and a highly potent, type 1b MET inhibitor. Here, we report phase I dose-escalation results for capmatinib in advanced MET-positive solid tumor patients and dos...
High-grade glioma (HGG) is the leading cause of cancer death among children. Selinexor, an orally bioavailable, reversible inhibitor of the nuclear export protein, exportin 1, is in clinical trials fo...
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Progressive diminution of the susceptibility of a human or animal to the effects of a drug, resulting from its continued administration. It should be differentiated from DRUG RESISTANCE wherein an organism, disease, or tissue fails to respond to the intended effectiveness of a chemical or drug. It should also be differentiated from MAXIMUM TOLERATED DOSE and NO-OBSERVED-ADVERSE-EFFECT LEVEL.
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
A treatment schedule in which the total dose of radiation is divided into large doses.
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...