Clinical trial · Interventional
A Study for Patients With Acute Leukemia
Phase 1 Study of LY2523355 in Patients With Acute Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Primary objective has been met in the absence of clinically meaningful remissions
Summary
Brief summary (as posted)
This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY2523355 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY2523355 on Days 1, 2, and 3
- description
- Starting dose was 2 milligrams per meter squared (mg/m\^2) administered by a 1-hour intravenous (IV) infusion on Days 1, 2, and 3 of every 21-day Cycle.
- interventionNames
- Drug: LY2523355
- type
- EXPERIMENTAL
- label
- LY2523355 on Days 1, 5, and 9
- description
- Starting dose was 8 milligrams per meter squared (mg/m\^2) administered by a 1-hour IV infusion over 1 hour on Days 1, 5, and 9 of every 21-day Cycle.
- interventionNames
- Drug: LY2523355
Primary outcomes (1)
- measure
- Recommended Dose and Schedule for Phase 2 Studies in Acute Leukemia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Dose escalation period for both schedules: * Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type and for whom experimental Phase 1 therapy is appropriate. * Are greater than or equal to 18 years of age. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug. Dose confirmation period for both schedules: * Participant must have a confirmed diagnosis of untreated acute myeloblastic leukemia (AML), should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or have acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen. * Are greater than or equal to 60 years of age. * Have a performance status of 0 or 1 on the ECOG scale. * Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug. Exclusion Criteria: * Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication. * Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment. * Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry. * Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved. * Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant. * Have uncontrolled systemic infection. * Females who are pregnant or lactating. * Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required).
References
Publications (0)
Data not yet available