Clinical Trial Details (PDF Generation Date :- Fri, 28 Sep 2018 17:28:30 GMT) CTRI Number Last Modified On 25/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/11/004124 [Registered on: 01/11/2013 - Trial Registered Retrospectively No Interventional Drug Single Arm Trial Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced Chronic Myeloid Leukemia A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate; OMA) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) Who have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 2007-001286-15 EudraCT CGX-635-CML-203 NCT00462943 Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Jayesh Mahajan Clinical Trial Manager Phone 02267863000 Fax 02267868009 Medpace Clinical Research Pvt. Ltd. Medpace Clinical Research Pvt. Ltd. Reliable Plaza, Ground Floor, Plot No. K-10, Kalwa Industrial Area,Thane - Belapur Road, MIDC Airoli Navi - 400708 j.mahajan@medpace.com Details Contact Person (Public Query) Jayesh Mahajan Clinical Trial Manager Medpace Clinical Research Pvt. Ltd. Medpace Clinical Research Pvt. Ltd. Reliable Plaza, Ground Floor, Plot No. K-10, Kalwa Industrial Area,Thane - Belapur Road, MIDC Airoli Navi - page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee 400708 Phone 02267863000 Fax 02267868009 j.mahajan@medpace.com Source of Monetary or Material Support > Teva Pharmaceutical Industries Ltd.(Previous Sponsor: ChemGenex Pharmaceuticals and Cephalon) Primary Sponsor Details ChemGenex Pharmaceuticals now Teva Pharmaceutical Industries Ltd Teva Pharmaceutical Industries Ltd. 5 Basel Street P O BOX 3190 Petach Tikva 49131 Israel Type of Sponsor NIL List of Countries Canada France Germany Hungary Italy Poland United Kingdom United States of America of Principal Investigator Dr Purvish Parikh Dr Raghunadharao Digumarti Pharmaceutical industry-global NIL of Site Site Phone/Fax/ n Cooperative Oncology Network (ICON) Nizams Institute of Medical Sciences (NIMS) Kashyap Nursing Home 09869715459 Imperial Mahal 02224145056 Khodadad Circle, Dadar purvish1@gmail.com TT 400 014 Room 607, E Block, 6th floor Panjagutta,500 082, Hyderabad ANDHRA PRADESH 04023372947 04066669049 telerama@rediffmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? ICON Ethics Committee, INSTITUTIONAL ETHICS COMMITTEE, NIZAM S INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD Approved 30/07/2008 No Approved 17/07/2008 No page 2 / 5
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Status Date Approved/Obtained 10/10/2008 Health Type Patients Condition Chronic Myeloid Leukemia Type Details Intervention Omacetaxine mepesuccinate Other s: Homoharringtonine, OMA, SynriboTM, HHT Comparator Agent Not Applicable Not Applicable Age From Age To Gender Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Induction Treatment: 1.25 mg per square meter subcutaneously twice daily for 14 consecutive days, every 28 days. Maintenance Treatment: 1.25 mg per square meter subcutaneously twice daily for 7 consecutive days, every 28 days. Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study. Note: Since there is no upper age limit defined for this trial, for the CTRI registration purpose we have included the upper age limit to be considered as 99 years. Male or female patients, age 18 years or older Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors. Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response). Acceptable Renal and Liver Function Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Exclusion Criteria Sexually active patients and their partners must use an effective double barrier method of contraception Exclusion Criteria page 3 / 5
Details New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label Myocardial infarction in the previous 12 weeks. Other concurrent illness which would preclude study conduct and assessment uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not. Pregnant or lactating. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol. Lymphoid Ph+ blast crisis Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent Primary Outcome Outcome Timepoints Percentage of Participants Achieving a Clinical Response by Subpopulation. Subpopulations reflect chronic myeloid leukemia (CML) phases: chronic, accelerated, and blast phase. Participants with Adverse Events by Subpopulation. Subpopulations reflect chronic myeloid leukemia (CML) phases: chronic, accelerated, and blast phase. Upto 6 months Upto 4 years Secondary Outcome Outcome Timepoints Time to Response The time from the initiation of treatment until the date of first reported hematologic or cytogenetic response. Duration of Response The time from the first reported date of hematologic or cytogenetic response, as defined above, until the earliest date of objective evidence of disease progression, relapse or death. Time to Disease Progression The time from the initiation of treatment until the onset date of death, the development of accelerated-phase or blast-crisis CML, or the loss of complete hematologic or major cytogenetic response, whichever comes first. Overall Survival The time from the initiation of treatment until up to 4 years [ Designated as safety issue: No up to 4 years [ Designated as safety issue: No up to 4 years [ Designated as safety issue: No page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary death from any cause or the last day of patient contact or evaluation for patients that are lost to follow-up. Participants Degree of Suppression of the Philadelphia Chromosome (Ph) Participants Degree of Suppression of BCR-ABL transcript levels Percentage of CML Participants with Accelerated or Blast Phase Who Return to Chronic Phase Percentage of CML Participants with Accelerated or Blast Phase Who Show No Evidence of Leukemia Percentage of Participants with Extramedullary Disease (EMD) at Baseline Who Achieve a Clinical Response The Number of Induction Cycles to Achieve a Clinical Response Total Sample Size=100 Sample Size from =30 30/10/2008 23/03/2007 Years=3 Months=0 Days=0 Completed Completed Up to four years [ Designated as safety issue: No up to four years [ Designated as safety issue: No up to four years [ Designated as safety issue: No Cortes J, Digumarti R, Parikh PM, Wetzler M, Lipton JH, Hochhaus A, Craig AR, Benichou AC, Nicolini FE, Kantarjian HM; Omacetaxine 203 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7. Omacetaxine mepesuccinate (omacetaxine) is a first-in-class cephalotaxine with a unique mode of action, independent of BCR-ABL, that has shown promising activity in patients with chronic myeloid leukemia (CML). This multicenter, noncomparative, open-label phase 2 study evaluated the efficacy and safety of subcutaneous omacetaxine in CML patients with resistance or intolerance to two or more tyrosine kinase inhibitors (TKIs). Patients received subcutaneous omacetaxine 1.25 mg/m² twice daily days 1-14 every 28 days until hematologic response (up to a maximum of six cycles), then days 1-7 every 28 days as maintenance. Subcutaneous omacetaxine may offer clinical benefit to patients with chronic-phase CML with resistance or intolerance to multiple TKI therapies. Total Patients participated from : 17 (7 from Dr. Parikh s site and 10 from Dr. Raghunadharao s site). Dr. Parikh s site is closed on 15-May-2013 and Dr. Raghunadharao s site is closed on 13-Jun-2013. page 5 / 5