NCT02078609
Completed
Phase 1
A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
ConditionsAML and High Risk MDS
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Incidence rate of dose limiting toxicities (DLTs) of LGH447 monotherapy arm in patients with AML or MDS and of LGH447 + midostaurin in patients with AML
Overview
Brief Summary
This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
LGH447 monotherapy arm
Experimental
LGH447 monotherapy in patients with AML or MDS
Intervention: LGH447 (Drug)
LGH447 + midostaurin combination arm
Experimental
LGH447 + midostaurin in patients with AML
Intervention: LGH447 + midostaurin (Drug)
Outcomes
Primary Outcomes
Incidence rate of dose limiting toxicities (DLTs) of LGH447 monotherapy arm in patients with AML or MDS and of LGH447 + midostaurin in patients with AML
Time Frame: 28 days post study treatment
Frequency and characteristics of dose limiting toxicities
Secondary Outcomes
- Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of the LGH447 monotherapy arm in patients with AML or MDS and of the LGH447 + midostaurin treatment arm in patients with AML(weekly to bi-weekly up to 1.5 years)
- PK parameters of the LGH447 monotherapy arm in patients with AML or MDS and of the LGH447 + midostaurin treatment arm in patients with AML(days 1, 2, 15, 16, 29, 30, 44, 57, and approximately monthly through Cycle 3)
- Changes between pre- and post-treatment levels of pS6RP and p4EBP1 in bone marrow aspirates and p4EBP1 in peripheral blood of the LGH447 monotherapy arm in patients with AML or MDS and of the LGH447 + midostaurin treatment arm in patients with AML(screening, days 1 and 29 up to 1.5 years)
- Anti-tumor activity in AML or high risk MDS associated wtih LGH447(Day 29 up to 1.5 years)
- Anti-tumor activity in AML or high risk MDS associated wtih LGH447 in combination with midostaurin(Day 29 up to 1.5 years)
Investigators
Study Sites (1)
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