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

Completed

• Conditions: acute myeloid leukemia and high risk myelodysplastic syndrome; 10018849

• Registration Number: NL-OMON44931
• Lead Sponsor: ovartis Pharma BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

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.

Exclusion Criteria

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
per day.
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence rate of dose limiting toxicities during the first cycle of LGH447<br /><br>with or without midostaurin treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical response, adverse events, dose interruptions, dose reductions, and<br /><br>dose intensity.</p><br>