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LY2090314 · 2 trials · 2 indications
Drug-related events were defined as treatment-emergent serious and other non-serious AEs that were considered by the investigator to be related to study drug. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of \>5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval.
| Arm | Type | Description |
|---|---|---|
| LY2090314 | EXPERIMENTAL | Cohort 1: 40 milligrams (mg) LY2090314 administered on Days 1, 8, and 15 of a 28-day cycle for at least two (2) 28-day cycles. Participants experiencing clinical benefit may continue treatment until after the discontinuation criteria are met. Due to a protocol amendment on September 2010, the study added 2 additional treatment schedules/cohorts. Cohort 2: 40 mg dose given on Days 1, 5, and 9 of a 21-day cycle. Cohort 3: 40 mg dose given on Days 1, 5, 9, and 12 of a 21-day cycle. Participants experiencing clinical benefit may continue treatment until after the discontinuation criteria are met. |
| LY2090314/pemetrexed/carboplatin | EXPERIMENTAL | Part A, Cycle 1 (28 days): Intravenous doses of LY2090314 starting at 10 milligram (mg) were given on Day 1 followed by 10 mg LY2090314, 500 milligram per square meter (mg/m\^2) pemetrexed (intravenous dose), and 5 or 6 area under the concentration-time curve (AUC) intravenous dose of carboplatin on Day 8. Part A, Cycle 2 (21 days): Pemetrexed and carboplatin given on Day 1 at the same dose administered in Cycle 1. Part A, Cycle 3 (21 days) and beyond: LY2090314, Pemetrexed and carboplatin were given on Day 1 at the same dose administered in Cycle 1. LY2090314 doses were escalated until the maximum tolerated dose (MTD) was reached. Part B: Dose determined in Part A was administered. Participants were allowed to continue the combination treatment if they were receiving therapeutic benefit until they fulfilled one of the criteria for discontinuation. |
| Name | Type | Description |
|---|---|---|
| LY2090314 | DRUG | Administered intravenously |
| pemetrexed | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
| ranitidine | OTHER | Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain. |
Inclusion Criteria: * Participants must have confirmed diagnosis of one of the following: * Acute myelogenous leukemia (AML) that is refractory or relapsed disease. If participants have acute promyelocytic leukemia (APL), they must have received prior all-trans retinoic acid and arsenic trioxide...
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LY2090314 is an investigational small molecule developed by Eli Lilly and Company for the treatment of advanced cancer and leukemia. It is a glycogen synthase kinase 3 (GSK3) inhibitor that has been studied in early-stage clinical trials. It is not approved for any indication and remains in clinical development.
LY2090314 has been studied in advanced or metastatic cancer and in acute leukemia. Clinical testing has focused on these oncology indications, with trials enrolling adults with advanced disease. The drug is investigational and has not been approved for any use.
LY2090314 targets GSK3B and GSK3A, the alpha and beta isoforms of glycogen synthase kinase 3. It acts as an inhibitor of these kinases. GSK3 is involved in multiple cellular signaling pathways, which is the basis for its investigation in cancer and leukemia.
LY2090314 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the clinical trials evaluating the compound in advanced cancer and leukemia.
LY2090314 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 study in advanced or metastatic cancer has been completed, and a Phase 2 study in acute leukemia has also been completed.
LY2090314 has been evaluated in two completed trials. NCT01287520 was a Phase 1 study in patients with advanced or metastatic cancer that enrolled 41 participants in the United States. NCT01214603 was a Phase 2 study in participants with acute leukemia that enrolled 20 participants.