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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 being studied for the treatment of advanced cancer and leukemia. It is being developed by Eli Lilly and Company for use in oncology. The drug has been evaluated in clinical trials involving participants with advanced or metastatic cancer and acute leukemia.
LY2090314 is a small molecule that targets glycogen synthase kinase-3 (GSK-3). By inhibiting this enzyme, the drug is being studied for its potential effects in cancer treatment. The exact mechanism of action is under investigation in clinical trials for advanced cancer and leukemia.
LY2090314 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The drug is an investigational small molecule in the oncology therapeutic area, currently being studied for advanced cancer and leukemia.
LY2090314 is in Phase 1 clinical development. It has completed a Phase 1 trial in patients with advanced or metastatic cancer and a Phase 2 trial in participants with acute leukemia. The drug is investigational and has not been approved by regulatory authorities.
LY2090314 has been studied in two completed clinical trials. NCT01287520 was a Phase 1 study in patients with advanced or metastatic cancer, enrolling 41 participants. NCT01214603 was a Phase 2 study in participants with acute leukemia, enrolling 20 participants. Both trials were conducted in the United States.
LY2090314 is the primary name for this investigational drug. No alternative names have been established for this compound in the available clinical trial information. The drug is identified by its LY2090314 designation in studies conducted by Eli Lilly and Company.