Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig 4103 Leipzig DeutschlandRekrutierend» Google-Maps Ansprechpartner: Uwe Platzbecker, MD E-Mail: uwe.platzbecker@medizin.uni-leipzig.de» Ansprechpartner anzeigenCharité Universitätsmedizin Berlin 13353 Berlin (Berlin) GermanyRekrutierend» Google-Maps Ansprechpartner: Jörg Westermann, MD E-Mail: joerg.westermann@charite.de» Ansprechpartner anzeigenThe Kirklin Clinic of UAB Hospital 35233 Birmingham United StatesRekrutierend» Google-Maps Ansprechpartner: Pankit Vachhani, MD E-Mail: jsregister@uabmc.edu» Ansprechpartner anzeigen
City of Hope Comprehensive Cancer Center 91010 Duarte United StatesAktiv, nicht rekrutierend» Google-MapsUniversity of California Irvine 92697 Irvine United StatesRekrutierend» Google-Maps Ansprechpartner: Deepa Jeyakumar, MD E-Mail: djeyakum@hs.uci.edu» Ansprechpartner anzeigenUCSD Moores Cancer Center 92093 La Jolla United StatesRekrutierend» Google-Maps Ansprechpartner: Carolyn Mulroney, MD E-Mail: camulroney@health.ucsd.edu» Ansprechpartner anzeigenUSC/Norris Comprehensive Cancer Center 90033 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Eric Tam, MD E-Mail: eric.tam@med.usc.edu» Ansprechpartner anzeigenStanford Cancer Center 94304 Palo Alto United StatesRekrutierend» Google-Maps Ansprechpartner: Gabriel Mannis, MD E-Mail: gmannis@stanford.edu» Ansprechpartner anzeigenUniversity of California, Davis 95817 Sacramento United StatesRekrutierend» Google-Maps Ansprechpartner: Brian Jonas Phone: 916-703-9151 E-Mail: bajonas@ucdavis.edu» Ansprechpartner anzeigenYale University 06520 New Haven United StatesRekrutierend» Google-Maps Ansprechpartner: Nikolai Podoltsev, MD E-Mail: nikolai.podoltsev@yale.edu» Ansprechpartner anzeigenUniversity of Miami - Miller School of Medicine 33136 Miami United StatesRekrutierend» Google-Maps Ansprechpartner: Justin Watts, MD E-Mail: jxw401@miami.edu» Ansprechpartner anzeigenEmory University 30322 Atlanta United StatesRekrutierend» Google-Maps Ansprechpartner: Martha Arellano Phone: 404-712-0720 E-Mail: marella@emory.edu» Ansprechpartner anzeigenMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Amir Fathi, MD» Ansprechpartner anzeigenDuke University Medical Center 27705 Durham United StatesRekrutierend» Google-Maps Ansprechpartner: Harry Erba, MD E-Mail: harry.erba@duke.edu» Ansprechpartner anzeigenCleveland Clinic - Taussig Cancer Center 44106 Cleveland United StatesRekrutierend» Google-Maps Ansprechpartner: Studipto Mukherjee, MD E-Mail: mukhers2@ccf.org» Ansprechpartner anzeigenThe Ohio State University Wexner Medical Center 43210 Columbus United StatesRekrutierend» Google-Maps Ansprechpartner: Uma Borate, MD E-Mail: uma.borate@osumc.edu» Ansprechpartner anzeigenMD Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-Maps Ansprechpartner: Naval Daver, Dr Phone: 713-792-6477 E-Mail: NDaver@mdanderson.org» Ansprechpartner anzeigenBorder Medical Oncology 2640 Albury AustraliaRekrutierend» Google-Maps Ansprechpartner: Anish Puliyayil, MD E-Mail: apuliyayil@bordermedonc.com.au» Ansprechpartner anzeigenRoyal Brisbane and Women's Hospital 4006 Herston AustraliaRekrutierend» Google-Maps Ansprechpartner: Steven Lane, MD» Ansprechpartner anzeigenTownsville University Hospital 4812 Townsville AustraliaRekrutierend» Google-Maps Ansprechpartner: Hock-Choong Lai, MD E-Mail: Hock.lai@health.qld.gov.au» Ansprechpartner anzeigenSt Vincent's Hospital Melbourne 3065 Fitzroy AustraliaRekrutierend» Google-Maps Ansprechpartner: Shuhying Tan, MD E-Mail: ShuhYing.TAN@svha.org.au» Ansprechpartner anzeigenSir Charles Gairdner Hospital 6009 Nedlands AustraliaRekrutierend» Google-Maps Ansprechpartner: Carolyn Grove, MD E-Mail: carolyn.grove@health.wa.gov.au» Ansprechpartner anzeigenKyungpook National University Hospital 41944 Daegu Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner: Sang-Kyun Sohn» Ansprechpartner anzeigenPusan National University Hospital 49241 Pusan Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner: Ho-Jin Shin» Ansprechpartner anzeigenSeoul National University Bundang Hospital 13620 Seongnam Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner: Jeong-Ok Lee» Ansprechpartner anzeigenSeoul National University Hospital 03080 Seoul Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner: Yunksuk Choi, MD Phone: +82-2-3010-3292 E-Mail: choiysmd@gmail.com» Ansprechpartner anzeigenSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-Maps Ansprechpartner: Chul-Won Jung Phone: +82-2-3410-2980 E-Mail: chulwon1.jung@samsung.com» Ansprechpartner anzeigenAuckland City Hospital 1023 Grafton New ZealandRekrutierend» Google-Maps Ansprechpartner: Leanne Berkahn, MD E-Mail: LeanneBerk@adhb.govt.nz» Ansprechpartner anzeigenHospital Universitario Central de Asturias 33011 Oviedo SpainRekrutierend» Google-Maps Ansprechpartner: Teresa Bernal E-Mail: bernaldelcastillo@gmail.com» Ansprechpartner anzeigenHospital Quirón Madrid 28223 Pozuelo De Alarcón SpainRekrutierend» Google-Maps Ansprechpartner: Carmen Martinez Chamorro, MD E-Mail: carmen.chamorro@quironsalud.es» Ansprechpartner anzeigenHospital Universitario Vall d'Hebron 08035 Barcelona SpainRekrutierend» Google-Maps Ansprechpartner: Olga Salamero, MD E-Mail: osalamero@vhio.net» Ansprechpartner anzeigenHospital Clinico Universitario de Valencia 46010 Valencia SpainRekrutierend» Google-Maps Ansprechpartner: Maria Tormo, MD E-Mail: tormo_mar@gva.es» Ansprechpartner anzeigenHospital Universitari i Politècnic La Fe 46026 Valencia SpainRekrutierend» Google-Maps Ansprechpartner: Pau Montesinos, MD E-Mail: montesinos_pau@gva.es» Ansprechpartner anzeigen
1. Recommended Phase 2 dose (Time Frame - 4 years): To determine the recommended phase 2 dose based on safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) consideration
2. Safety of HM43239 (Time Frame - 4 years): Determine the maximum tolerated dose at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML
3. Tolerability of HM43239 (Time Frame - 4 years): To determine the frequency and severity of drug-related adverse events across different dose levels when administered in patients with R/R AML
4. Safety of HM43239 in combination with venetoclax (Time Frame - 4 years): Determine the maximum tolerated dose of HM43239 in combination with venetoclax at which no more than 1 out of 6 patients experience a dose-limiting toxicity or establish the safety of clinically effective dose below the MTD if the MTD is not reached.relapsed or treatment-refractory (R/R) AML
5. Tolerability of HM43239 in combination with venetoclax (Time Frame - 4 years): To determine the frequency and severity of drug-related adverse events across different dose levels of HM43239 in combination with venetoclax when administered in patients with R/R AML
Secondary outcome:
1. Anti-leukemic activity of HM43239 (Time Frame - 4 years): To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239
2. Anti-leukemic activity of HM43239 in combination with venetoclax (Time Frame - 4 years): To investigate the rate of complete remission (CR), CR with partial hematologic recovery (CRh), CR with incomplete platelet recovery (CRp), CR with incomplete hematologic recovery (CRi), and partial remission (PR) of patients taking HM43239 in combination with venetoclax
3. Pharmacokinetic variables including maximum plasma concentration (Cmax) (Time Frame - Cycle 1 (at least 28 days)): Pharmacokinetic variables including maximum plasma concentration (Cmax)
4. Pharmacokinetic variables including minimum plasma concentration (Cmin) (Time Frame - Cycle 1 (at least 28 days)): Pharmacokinetic variables including minimum plasma concentration (Cmin)
5. Pharmacokinetic variables including area under the curve (AUC) (Time Frame - Cycle 1 (at least 28 days)): Pharmacokinetic variables including area under the curve (AUC)
6. Pharmacokinetic variables including volume of distribution (Time Frame - Cycle 1 (at least 28 days)): Pharmacokinetic variables including volume of distribution
7. Pharmacokinetic variables including clearance (Time Frame - Cycle 1 (at least 28 days)): Pharmacokinetic variables including clearance
8. Pharmacodynamic variables (Time Frame - 4 years): Determine PD variables by using a plasma inhibitory activity assay (PIA assay) examining the reduction in phospho-STAT5 and phospho-FLT3 in cell lines exposed to plasma from subjects treated in the study.
Experimental: Part A Dose Escalation For Part A (tuspetinib as a single agent), dose escalation cohort is planned up to 6 dose levels. If a subject in the dose escalation cohort at any dose level achieves clinical response then the dose level will continue to enroll in Part B. If one DLT or less is observed in the 6 patients (<1/6 DLT observed) in Part A, up to 20 evaluable patients can be enrolled in Part B at that dose level.
Experimental: Part B Dose Exploration For Part B (tuspetinib as a single agent), dose exploration cohort is planned up to 4 dose levels.
Experimental: Part C Dose Expansion (tuspetinib as a single agent) Part C, dose expansion, consists of 2 arms (tuspetinib as a single agent or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the single arm will be 120mg.
Experimental: Part C Dose Expansion (Combination Arm - tuspetinib and venetoclax) Part C, dose expansion, consists of 2 arms (tuspetinib or tuspetinib plus venetoclax). Patients will be randomly assigned to either arm based on the number of slots available. The initial tuspetinib dose for the combo arm will be 80mg.
Venetoclax Oral Tablet (Venetoclax): Venetoclax will be given to patients in combo treatment group (Part C) either in 50 mg or 100 mg tablets
Quelle: ClinicalTrials.gov
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