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1 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: ASP 2215-cl-0101 Previous Study Return to List Next Study Dose Escalation Study Inv e stigating the Safe ty, Tole rability, Pharmacokine tics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute M yeloid Leukemia This study is ongoing, but not recruiting participants. Sponsor: Astellas Pharma Global Development, Inc. Information prov ided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) ClinicalTrials.gov Identifier: NCT First received: November 6, 2013 Last updated: September 30, 2015 Last verified: September 2015 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose The objective of this study is to assess the safety and tolerability, including the maximum tolerated dose, of ASP2215 in subjects w ith relapsed or treatment-refractory acute myeloid leukemia (AML). This study w ill also determine the pharmacokinetic (PK) parameters of ASP2215. Condition Interv ention Phase Acute Myeloid Leukemia Drug: ASP2215 Phase 1 Phase 2 Study Type: Study Design: Official Title: Interventional Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Resource links prov ided by NLM: Genetics Home Reference related topics: core binding factor acute myeloid leukemia familial acute myeloid leukemia w ith mutated CEBPA cytogenetically normal acute myeloid leukemia MedlinePlus related topics: Acute Myeloid Leukemia Leukemia Genetic and Rare Diseases Information Center resources: Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myeloid Leukemia U.S. FDA Resources Further study details as prov ided by Astellas Pharma Inc: Primary Outcome Measures: Safety and Tolerability assessed through adverse events to determine maximum tolerated dose [ Time Frame: up to 18 months ] Pharmacokinetics of ASP2215: AUC24 [ Time Frame: Day -2 pre-dose and up to Day 22 in Cycle 1 and pre-dose on Day 1 of each cycle subsequent 28 day cycle for an expected average of 4 cycles ] Area under the plasma concentration time curve at 24 hours

2 Pharmacokinetics of ASP2215: Cmax [ Time Frame: Day -2 pre-dose and up to Day 22 in Cycle 1 and pre-dose on Day 1 of each cycle subsequent 28 day cycle for an expected average of 4 cycles ] Maximum Concentration Pharmacokinetics of ASP2215: Ctrough [ Time Frame: Day -2 pre-dose and up to Day 22 in Cycle 1 and pre-dose on Day 1 of each cycle subsequent 28 day cycle for an expected average of 4 cycles ] Minimum Concentration Pharmacokinetics of ASP2215: tmax [ Time Frame: Day -2 pre-dose and up to Day 22 in Cycle 1 and pre-dose on Day 1 of each cycle subsequent 28 day cycle for an expected average of 4 cycles ] Time to attain Cmax Secondary Outcome Measures: Complete Remission (CR) Rate [ Time Frame: up to 18 months ] Overall Survival [ Time Frame: up to 18 months ] Event Free Survival [ Time Frame: Up to 18 months ] Leukemia free survival [ Time Frame: up to 18 months ] Pharmacokinetics of ASP2215 in co-administration w ith strong or moderate CYP3A4 (Cytochrome P450-isozyme3A4) inhibitors: AUC24 [ Time Frame: Pre-dose, Day 1, Cycle 1 and up to Cycle 2, Day 1 ] Area under the plasma concentration time curve at 24 hours for ASP2215 as single agent and w hen combined w ith CYP3A4 inhibitor Pharmacokinetics of ASP2215 in co-administration w ith strong or moderate CYP3A4 (Cytochrome P450-isozyme3A4) inhibitors: Cmax [ Time Frame: Pre-dose, Day 1, Cycle 1 and up to Cycle 2, Day 1 ] Maximum Concentration for ASP2215 as single agent and w hen combined w ith CYP3A4 inhibitor Pharmacokinetics of ASP2215 in co-administration w ith strong or moderate CYP3A4 (Cytochrome P450-isozyme3A4) inhibitors: Ctrough [ Time Frame: Pre-dose, Day 1, Cycle 1 and up to Cycle 2, Day 1 ] Minimum Concentration for ASP2215 as single agent and w hen combined w ith CYP3A4 inhibitor Pharmacokinetics of ASP2215 in co-administration w ith strong or moderate CYP3A4 (Cytochrome P450-isozyme3A4) inhibitors: tmax [ Time Frame: Pre-dose, Day 1, Cycle 1 and up to Cycle 2, Day 1 ] Time to attain Cmax for ASP2215 as single agent and w hen combined w ith CYP3A4 inhibitor Pharmacokinetics of midazolam in co-administration w ith ASP2215: AUC24 [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Area under the plasma concentration time curve at 24 hours for midazolam as single agent and w hen combined w ith ASP2215 Pharmacokinetics of midazolam in co-administration w ith ASP2215: Cmax [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Maximum Concentration for midazolam as single agent and w hen combined w ith ASP2215 Pharmacokinetics of midazolam in co-administration w ith ASP2215: Ctrough [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Minimum Concentration for midazolam as single agent and w hen combined w ith ASP2215 Pharmacokinetics of midazolam in co-administration w ith ASP2215: tmax [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Time to attain Cmax for midazolam as single agent and w hen combined w ith ASP2215 Composite CR rate [ Time Frame: up to 18 months ] CR + Complete remission w ith incomplete platelet recovery (CRp) + Complete remission w ith incomplete hematologic recovery (CRi) Best response rate [ Time Frame: up to 18 months ] Composite complete remission (CRc) + partial remission (PR)

3 Duration of response [ Time Frame: up to 18 months ] Pharmacokinetics of cephalexin in co-administration w ith ASP2215: AUC24 [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Area under the plasma concentration time curve at 24 hours for cephalexin as single agent and w hen combined w ith ASP2215 Pharmacokinetics of cephalexin in co-administration w ith ASP2215: Cmax [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Maximum Concentration for cephalexin as single agent and w hen combined w ith ASP2215 Pharmacokinetics of cephalexin in co-administration w ith ASP2215: Ctrough [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Minimum Concentration for cephalexin as single agent and w hen combined w ith ASP2215 Pharmacokinetics of cephalexin in co-administration w ith ASP2215: tmax [ Time Frame: Pre-dose and up to Day 15 in Cycle 1 ] Time to attain Cmax for cephalexin as single agent and w hen combined w ith ASP2215 Enrollment: 258 Study Start Date: October 2013 Estimated Study Completion Date: June 2018 Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure) Arms Experimental: Dose Escalation Cohort Assigned Interv entions Drug: ASP2215 tablet Experimental: Dose Expansion Cohort Drug: ASP2215 tablet Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No Criteria Inclusion Criteria: Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the follow ing: Refractory to at least 1 cycle of induction chemotherapy Relapsed after achieving remission w ith a prior therapy Subject has an Eastern Cooperative Oncology Group (ECOG) performance status 2. Subject's interval from prior treatment to time of study drug administration is at least 2 w eeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents. Subject must meet the follow ing criteria as indicated on the clinical laboratory tests*: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x institutional upper limit normal (ULN) Total serum bilirubin < 1.5x institutional ULN Serum creatinine < 1.5 x institutional ULN or an estimated glomerular filtration rate (egfr) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation. Subject agrees not to participate in another interventional study w hile on treatment. Exclusion Criteria: Subject w as diagnosed as acute promyelocytic leukemia (APL). Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis). Subject has active malignant tumors other than AML or Myelodysplastic syndrome (MDS).

4 Subject has persistent nonhematological toxicities of >= Grade 2 (Common Terminology Criteria for Adverse Events v4), w ith symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery). Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the follow ing: Is w ithin 2 months of transplant from C1D1 Has clinically significant graft-versus-host disease requiring treatment Has >= Grade 2 persistent non-hematological toxicity related to the transplant. Donor lymphocytes infusion (DLI) is not permitted <= 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first tw o cycles of the treatment in Cohort 2 Subject has clinically active central nervous system leukemia Subject has disseminated intravascular coagulation abnormality (DIC) Subject has had major surgery w ithin 4 w eeks prior to the first study dose. Subject has had radiation therapy w ithin 4 w eeks prior to the first study dose Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject w ith a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed w ithin 3 months prior to study entry results in a left ventricular ejection fraction that is 45% Subject requires treatment w ith concomitant drugs that are strong inhibitors or inducers of Cytochrome P450-isozyme3A4 (CYP3A4) w ith the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject Subject required treatment w ith concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor w ith the exception of drugs that are considered absolutely essential for the care of the subject. Subject has an active uncontrolled infection Subject is know n to have human immunodeficiency virus infection Subject has active hepatitis B or C, or other active hepatic disorder Contacts and Locations Choosing to participate in a study is an important personal decision. Talk w ith your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier: NCT Show 32 Study Locations Sponsors and Collaborators Astellas Pharma Global Development, Inc. Inv estigators Study Director: Executive Medical Director Astellas Pharma Global Development More Information No publications provided Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) ClinicalTrials.gov Identifier: NCT History of Changes Other Study ID Numbers: 2215-CL-0101 Study First Received: November 6, 2013 Last Updated: September 30, 2015 Health Authority: United States: Food and Drug Administration Italy: The Italian Medicines Agency France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Keyw ords provided by Astellas Pharma Inc: Acute Myeloid Leukemia ASP2215 Additional relevant MeSH terms: Leukemia

5 Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type ClinicalTrials.gov processed this record on January 07, 2016

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