(藥華)P1101 用於早期Myelofibrosis (Phase 2) 骨髓硬化症評估 ! (AOP2014, , PEG-P-IFN-Alfa-2b, PEG-P-IFN-Alpha-2b)

藥華醫藥:澄清媒體報導 鉅亨網 2016/03/29  第三十四條第42款1.事實發生日:105/03/292.公司名稱:藥華醫藥股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:工商時報報導 藥華藥在去年有幾項成功的突破，包括獲美國食品藥物管理局(FDA)核准 P1101在美國進行PMF(Primary Myelofibrosis)原發性骨髓纖維化的人體試驗。6.因應措施:本公司予以說明如下 藥華藥在去年有幾項成功的突破，包括獲美國食品藥物管理局(FDA)核准P1101 在美國進行PMF(Primary Myelofibrosis)原發性骨髓纖維化的人體試驗，本試驗是屬IIT(Investigator initiated Trial)由計畫主持醫生向FDA申請核准。7.其他應敘明事項:無

P1101 in Treating Patients With Early Myelofibrosis (Phase 2)

Primary Outcome Measures: Best overall response (CR, PR, or CI) as determined by International Working Group Criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Secondary Outcome Measures: Incidence of adverse events, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4) [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ] The distribution of survival time will be estimated using the method of Kaplan-Meier.

Other Outcome Measures: Changes in patient-reported symptoms and QOL as measured by MPN-SAF [ Time Frame: Baseline to up to 3 years ] [ Designated as safety issue: No ] Patient-reported symptoms and QOL will be described at each time point using the mean, confidence interval, median, and range. Changes in individual symptoms, changes in a symptom scale composed of symptoms specific to MF patients, and changes in the MPN TSS will be investigated. Graphical procedures will include stream plots of individual patient scores and plots of average values over time. Correlational analyses will be done to determine the relationships among patients-reported symptoms and QOL, as well as with clinical outcomes and clinician-assessed symptoms.

Estimated Enrollment:  12/ Study Start Date:     August 2015/ Estimated Primary Completion Date:   March 2020 (Final data collection date for primary outcome measure) Experimental: Treatment (PEG-proline-interferon alpha-2b), Patients receive PEG-proline-interferon alpha-2b SC on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Other: Laboratory Biomarker Analysis,, Correlative studies, Biological: PEG- Proline-Interferon Alfa-2b/Given SC/ Other Names:, AOP2014, P1101, PEG-P-IFN-Alfa-2b, PEG-P-IFN-Alpha-2b/Other:Quality-of-Life Assessment,Ancillary studies,Other Name: Quality of Life Assessment

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate for clinical response (complete remission [CR], partial remission [PR], or clinical improvement [CI]) as defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. SECONDARY OBJECTIVES: I. To evaluate the adverse event profile of P1101 in patients with myelofibrosis. II. To evaluate the tolerability of P1101 in patients with myelofibrosis. TERTIARY OBJECTIVES: I. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) with P1101 for patients with myelofibrosis. II. To evaluate the impact of P1101 on bone marrow and histological features of myelofibrosis including cytogenetics, blast percentage, fibrosis, and janus kinase 2 (JAK2)-V617F allele burden. OUTLINE: Patients receive PEG-proline-interferon alpha-2b subcutaneously (SC) on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 3 years.

Locations: United States, Arizona ,Mayo Clinic in Arizona Recruiting, Scottsdale, Arizona, United States, 85259 Contact: Clinical Trials Referral Office 855-796-0015, Principal Investigator: Ruben A. Mesa, Sponsors and Collaborators, Mayo Clinic, National Cancer Institute (NCI), Investigators, Principal Investigator:   Ruben Mesa, Mayo Clinic     

Myelofibrosis骨髓纖維化髓外生/ 簡稱髓纖，是一種由於骨髓造血組織中膠原增生，其纖維組織嚴重地影響造血功能所引起的一種骨髓增生性疾病，原發性髓纖又稱 骨髓硬化症