A phase I, multicenter, open-label study of oral LGH447 in patients with acute myeloid leukemia or high risk myelodysplastic syndrome (CLGH447X2102) - CLGH447X2102

ovartis Pharma BV0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1. Male or female patients *18 years.with refractory/relapsed AML (see protocol page 44 for details).
•2. Patients with active CNS disease are eligible and may be treated concurrently with intrathecal (or intra Ommaya) chemotherapy.
•3. Patients are eligible as long as previous and concomitant medications are in line with the with the list of approved concomitant medications (see protocol appendix 5 for details).
•4. ECOG performance status 0-2.

•1. Systemic antineoplastic therapy or any experimental therapy within 7 days or 5 half-lives, whichever is longer, before the first dose of LGH447 with or without midostaurin (see protocol page 45 for further details).
•2. Radiotherapy with a wide field of radiation within 28 days or radiotherapy with a limited
•field of radiation for palliation within 7 days of the first dose of LGH447 with or without midostaurin.
•3. CNS irradiation for meningeal leukemia, except if radiotherapy occurred > 3 months previously.
•4. Ongoing systemic therapy with corticosteroids greater than 10 mg of prednisone or its equivalent
•5. Uncontrolled cardiovascular condition within the past 6 months.
•6. Active infection requiring systemic therapy or other severe infection with 2 weeks before the first dose of LGH447.
•7. Currently receiving hydroxyurea to control peripheral blood leukemic
•blasts that cannot be discontinued for at least 48 hours prior to obtaining PD biomarkers at
•screening/baseline and during the study.
•8. Other prohibited medications (see protocol page 27 for details).
•9. Pregnancy, lactation.
•10. Inadequate contraception for women of childbearing potential (see protocol page 46 for details).
•11 Sexually active males must use a condom during intercourse while taking the drug and for
•96 days after stopping treatment and should not father a child in this period.

发起方

ovartis Pharma BV