Kompetenznetz-leukaemie.de

Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
I3X-MC-JHTB
Öffentlicher Titel
Wissenschaftl. Titel
A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms Kurztitel
Studiennummer KN/ELN
Studiengruppe
Studienart
multizentrisch, einarmig, prospektiv, offen Studienphase
Erkrankung
Myeloproliferative Erkrankung( MPN) Alle Subtypen Leukämiestadium
Haupt- und
Percentage of Participants with an Objective Response (Objective Response Rate) Nebenzielkriterien
[Baseline until Disease Progression (PD) or Participant Stops Study (Estimated up to24 Months)] (Hauptzielkriterium) Percentage of Participants with a Molecular Response (Molecular Response Rate)[Baseline until PD or Participant Stops Study (Estimated up to 24 Months)] Percentage of Participants with Hematological Improvement (HematologicalImprovement Rate) [Baseline until PD or Participant Stops Study (Estimated up to 24Months)] Change in Spleen Size [Baseline until PD or Participant Stops Study (Estimated up to24 Months)] Change in Bone Marrow Fibrosis Grade [Baseline until PD or Participant Stops Study(Estimated up to 24 Months)] Change in Number of Thrombotic or Hemorrhagic Events [3 Months prior to StudyDrug (historic) until PD or Participant Stops Study (Estimated up to 24 Months)] Change in Number of Phlebotomies and Transfusions [Baseline until PD orParticipant Stops Study (Estimated up to 24 Months)] Duration of Response [Confirmed Response to PD or Death from Any Cause(Estimated up to 24 Months)] Time to Best Response [Baseline to Confirmed Response (Estimated up to 6Months)] Change in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)[Baseline until PD or Participant Stops Study (Estimated up to 24 Months)] Time to Treatment Failure [Baseline to PD, Death from Any Cause or ParticipantStops Study (Estimated up to 24 Months)] Time to Disease Progression [Baseline to Measured PD (Estimated up to 24 Months)] Progression Free Survival (PFS) [Baseline to PD or Death from Any Cause(Estimated up to 24 Months)] Change in Activities of Daily Living (ADL)/ Instrumental Activities of Daily Living(IADL) [Baseline until PD or Participant Stops Study (Estimated up to 24 Months)] Change in EuroQol - 5 dimensions (EQ-5D) Index Score [Baseline until PD orParticipant Stops Study (Estimated up to 24 Months)] Change in International Prognosis Scoring System Scales (IPSS) [Baseline until PDor Participant Stops Study (Estimated up to 24 Months) ] Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2784544 [Predose upto Day 84] PK: Time of Maximal Concentration (Tmax) of LY2784544 [Predose up to Day 84] Change in Liver Size [Baseline until PD or Participant Stops Study (Estimated up to24 Months)] Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
I3X-MC-JHTB
Change in 6-item Physician Symptom Assessment [Baseline until PD or ParticipantStops Study (Estimated up to 24 Months)] Einschlusskriterien
Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), ormyelofibrosis (MF) as defined by the World Health Organization (WHO) diagnosticcriteria for myeloproliferative neoplasms (Swerdlow et al. 2008) and meet thefollowing additional subtype specific criteria: 1. PV: have failed or is intolerant of standard therapies or refuses to take standardmedications 2. ET: have failed or is intolerant of standard therapies or refuses to take standardmedications 3. MF (participants with MF must meet at least 1 of the following): have intermediate1, intermediate 2, or high-risk MF according to the Dynamic International PrognosticScoring System (DIPPS Plus) for Primary Myelofibrosis (Gangat et al. 2011); or havesymptomatic MF with spleen greater than 10 centimeter (cm) below left costalmargin; or have post-polycythemic MF; or have post-ET MF All PV, ET, and MF participants must meet the following criteria: Have a quantifiablelevel of janus kinase 2 with a valine to phenylalanine substitution at amino acid 617(JAK2 V617F) mutation. This inclusion criterion will not apply to the subset ofparticipants in Cohorts 10 and 11 that must be negative for the JAK2 V617F mutation Have given written informed consent prior to any study-specific procedures Have adequate organ function, including: Hepatic: Direct bilirubin <=1.5 times upperlimits of normal (ULN), alanine transaminase (ALT), and aspartate transaminase(AST) <=2.5 times ULN; Renal: Serum creatinine <=1.5 times ULN; Bone MarrowReserve: Absolute neutrophil count (ANC) >=1000/microliter (mcL), platelets>=50,000/mcL for participants with ET or PV and >=25,000/mcL for participants withMF Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group(ECOG) scale Have discontinued all previous approved therapies for Myeloproliferative Neoplasms(MPNs), including any chemotherapy, immunomodulating therapy (for example,thalidomide, interferon-alpha), immunosuppressive therapy (for example,corticosteroids >10 mg/day prednisone or equivalent), radiotherapy, anderythropoietin, thrombopoietin, or granulocyte colony stimulating factor for at least 14days and recovered from the acute effects of therapy. Hydroxyurea used to controlblood cell counts is permitted at study entry if the subject has been maintained on astable dose for at least 4 weeks. Low-dose acetylsalicylic acid (aspirin) is permittedas well Are reliable and willing to make themselves available for the duration of the study andare willing to follow study procedures Males and females with reproductive potential must agree to use medically approvedcontraceptive precautions during the study and for 3 months following the last dose ofstudy drug Females with child-bearing potential must have had a negative urine pregnancy test 7 days before the first dose of study drug and must also not be breastfeeding For participants who have undergone recent major surgery, at least 28 days musthave elapsed between surgery and study participation and the participant must haveachieved, in the opinion of the treating physician, at least a good recovery from thesurgical procedure Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
I3X-MC-JHTB
Enrollment into Cohort 12 is limited to MF, PV, or ET participants, regardless ofmutational status, who, in addition to all other criteria, have demonstrated intoleranceto ruxolitinib, failure of primary response to ruxolitinib, or have demonstrated diseaseprogression while on ruxolitinib Ausschlusskriterien
Are currently enrolled in, or discontinued within the last 14 days from a clinical trialinvolving an investigational product or non-approved use of a drug or device, orconcurrently enrolled in any other type of medical research judged not to bescientifically or medically compatible with this study Have a corrected QT (QTc) interval >470 millisecond (msec) using Bazett's formula Have serious preexisting medical conditions that, in the opinion of the investigatorwould preclude participation in the study (for example a gastrointestinal disordercausing clinically significant symptoms such as nausea, vomiting, and diarrhea, ormalabsorption syndrome) Are currently being treated with agents that are metabolized by Cytochrome P4503A4 enzyme (CYP3A4) with a narrow therapeutic margin (for example, alfentanil,cyclosporine, diergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, andtacrolimus) or Cytochrome P450 2B6 enzyme (CYP2B6) (for example,cyclophosphamide, ifosfamide, tamoxifen, efavirenz, propofol, methadone, andbupropion) Are currently being treated with warfarin or one of its derivatives which is known toalter levels of protein C or protein S. An exception to this criterion will be allowed forparticipants with a prior history of Budd-Chiari Syndrome who are being treated withwarfarin or one of its derivatives Have received a hematopoietic stem cell transplant Have a second primary malignancy that in the judgment of the Investigator andSponsor may affect the interpretation of results Have an active fungal, bacterial, and/or known viral infection including humanimmunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required) Have a history of congestive heart failure with New York Heart Association (NYHA)Class >2 (NYHA Class 1 and 2 are eligible), unstable angina, recent myocardialinfarction (within 6 months prior to administration of study drug), or documentedhistory of ventricular arrhythmia Beginn der Rekrutierung
Rekrutierende Länder
Fallzahl
Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit, Kompetenznetz "Akute und chronische Leukämien"
KURZPROTOKOLL
I3X-MC-JHTB
Studienleiter/in
Griesshammer, Prof. Dr. med., MartinHans-Nolte-Strasse 132429 MindenTel: +49 (0)571 790-54201Fax: +49 (0)571 790-291650E-Mail: Sponsoren
Förderer
Registrierung in anderen
ClinicalTrials.govNCT01594723 (primäres Register) Studienregistern
Informationszentrum im Kompetenznetz Leukämien | Deutsches Leukämie Studienregister Ohne Gewähr für Richtigkeit oder Vollständigkeit,

Source: http://www.kompetenznetz-leukaemie.de/trial/pdf/knl_de/kurzprotokoll_LN_NN_2012_521.pdf?id=521