[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07036133":3,"trial-entities:NCT07036133":134,"trial-summary:NCT07036133":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":70,"locations":73,"central_contacts":118,"overall_officials":128,"references":132,"see_also_links":133},"NCT07036133","FOL-102","Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment","A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment","RECRUITING","2027-09","2026-02","2026-02-11","2022-12-28","Acrotech Biopharma Inc.","INDUSTRY",false,"This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment. Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.","This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.",[19,20],"Advanced Solid Tumors","Hematologic Malignancies",[22],"Pralatrexate","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},24,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Pralatrexate Injection","Pralatrexate will be administered based on Child-Pugh Classification of liver impairment",[36],"Open-label treatment with Pralatrexate",[38],{"measure":39,"description":40,"timeFrame":41},"To evaluate the pharmacokinetic (PK) profile of pralatrexate.","Blood will be collected to evaluate the pharmacokinetic (PK) profile of pralatrexate (plasma concentration levels) when administered to patients with various degrees of hepatic impairment.","During week 1 of the first cycle of treatment (each cycle is 7 weeks).",[43],{"measure":44,"description":45,"timeFrame":46},"To evaluate the safety of pralatrexate","The number and severity of treatment-related adverse events. This will be as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale, Version 5.0.","This will be evaluated during the study through 14(±3) days after the last dose in Cycle 1, or 35(±5) days after the final dose in any cycle or until all treatment-related AEs have resolved or returned to Baseline\u002FGrade","ALL","18 Years",null,{"inclusion":51,"exclusion":60,"raw_text":69},[52,53,54,55,56,57,58,59],"Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements","Patient is diagnosed with advanced solid tumor or hematological malignancy.","Patient is at least 18 years of age and has a life expectancy of at least 6 months.","Patient has normal or abnormal hepatic function as defined by normal, mild (Child-Pugh A), moderate (Child-Pugh B ), or severe (Child-Pugh C) liver impairment","Patient has adequate hematologic and renal function as defined by:","Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.","Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of pralatrexate","Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or who are surgically sterilized do not require this test.",[61,62,63,64,65,66,67,68],"Patient has had previous exposure to pralatrexate","Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.","Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive the protocol-defined treatment.","Patient has known or suspected intolerance or hypersensitivity to the investigational product or any related compound.","Patient has congestive heart failure at Class III\u002FIV according to the New York Heart Association (NYHA) Functional Classification","Patient has had major surgery within 30 days prior to enrollment.","Patient with central nervous system (CNS) metastases","Patient is pregnant or breast-feeding.","Inclusion Criteria:\n\n* Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements\n* Patient is diagnosed with advanced solid tumor or hematological malignancy.\n* Patient is at least 18 years of age and has a life expectancy of at least 6 months.\n* Patient has normal or abnormal hepatic function as defined by normal, mild (Child-Pugh A), moderate (Child-Pugh B ), or severe (Child-Pugh C) liver impairment\n* Patient has adequate hematologic and renal function as defined by:\n\nAbsolute neutrophil count (ANC) ≥1000\u002FμL Platelet count ≥100,000\u002FμL Creatinine ≤ 1.5 mg\u002FdL or calculated creatinine clearance ≥50 mL\u002Fmin\n\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of pralatrexate\n* Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or who are surgically sterilized do not require this test.\n\nExclusion Criteria:\n\n* Patient has had previous exposure to pralatrexate\n* Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.\n* Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive the protocol-defined treatment.\n* Patient has known or suspected intolerance or hypersensitivity to the investigational product or any related compound.\n* Patient has congestive heart failure at Class III\u002FIV according to the New York Heart Association (NYHA) Functional Classification\n* Patient has had major surgery within 30 days prior to enrollment.\n* Patient with central nervous system (CNS) metastases\n* Patient is pregnant or breast-feeding.",[71,72],"ADULT","OLDER_ADULT",[74,84,96,107],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"TOI Clinical Research","WITHDRAWN","Cerritos","California","90703","United States",{"lat":82,"lon":83},33.85835,-118.06479,{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":80,"contacts":89,"geoPoint":93},"Northwestern University - Feinberg School of Medicine","Chicago","Illinois","60611",[90],{"name":91,"role":92},"Devalingam Mahalingam, MD","PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},41.85003,-87.65005,{"facility":97,"status":8,"city":98,"state":99,"zip":100,"country":80,"contacts":101,"geoPoint":104},"Karmanos Cancer Institute","Detroit","Michigan","48201",[102],{"name":103,"role":92},"Wasif Saif, MD",{"lat":105,"lon":106},42.33143,-83.04575,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":80,"contacts":112,"geoPoint":115},"Gabrail Cancer Center","Canton","Ohio","44718",[113],{"name":114,"role":92},"Nashat Gabrail, MD",{"lat":116,"lon":117},40.79895,-81.37845,[119,124],{"name":120,"role":121,"phone":122,"email":123},"Uma Srinivas Atmuri","CONTACT","732-917-2420","uatmuri@acrotechbiopharma.com",{"name":125,"role":121,"phone":126,"email":127},"Motun Clinical Trial Manager","617-694-4296","msolomon@acrotechbiopharma.com",[129],{"name":130,"role":131},"Erard Gilles, MD, MSc","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":135,"biomarkers":138},[136,137],"Hematologic Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":140,"summary":141,"prompt_version":151},true,{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is an open-label, multi-center study that is not randomized. It plans to include 24 participants.","completed","Pralatrexate for Advanced Solid Tumors or Blood Cancers with Liver Impairment","This study is looking at how your body handles a medicine called pralatrexate, which is used to treat advanced solid tumors or blood cancers. Researchers want to understand how pralatrexate is absorbed, broken down, and removed (this is called pharmacokinetics or PK) in people with different levels of liver function. They also want to check the safety of pralatrexate and figure out the best dose for people with liver problems. You might be able to join if you are at least 18 years old, have an advanced solid tumor or blood cancer, and have a life expectancy of at least 6 months. The study aims to see how pralatrexate works in your body during the first week of treatment.","The primary endpoint is measured during week 1 of the first cycle of treatment (each cycle is 7 weeks).",119,"You would need to be willing to give written informed consent and follow the dosing and visit schedules, as well as all study requirements. Pralatrexate will be given once weekly for 6 weeks of every 7-week treatment cycle.","Not stated in the trial record.",[],"v2"]