Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2228820 · 2 trials · 4 indications
Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).
PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after the administration of at least 1 dose of study drug, regardless of causality. A summary of serious AEs (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Phase 1b (Cohort 1) LY2228820 200 milligrams (mg) | EXPERIMENTAL | Cohort 1: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 milligrams per square meter (mg/m\^2) administered intravenously (IV) over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.. Cohort 1: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14. |
| Phase 1b (Cohort 2) LY2228820 300 mg | EXPERIMENTAL | Cohort 2: Cycles 1-6 (21 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Cohort 2: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14. |
| Phase 2 (Arm A) LY2228820 200 mg | EXPERIMENTAL | Arm A: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm A: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14. |
| Phase 2 (Arm B) Placebo | PLACEBO_COMPARATOR | Arm B: Cycles 1-6 (21 day cycles)- Placebo administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3. Arm B: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind. |
| LY2228820 | EXPERIMENTAL | The study had 4 parts, dose-escalation (Part A), 2 dose-confirmation (Parts B and C), and a tumor-specific expansion for metastatic breast cancer (Part D). Part A: Participants received escalating doses of 10, 20, 40, 65, 90, 120, 160, 200, 300, 420 and 560 milligrams (mg) of LY2228820 every 12 hours on Days 1 through 14 of a 28-day cycle. Part B: Participants received 420 mg of LY2228820 every 12 hours Days 1 through 14 of a 28-day cycle. Participants received midazolam orally 2 days before the first dose and again after the morning dose of study drug on Day 8 during the first cycle of treatment. Part C: Participants received 300 mg of LY2228820 every 12 hours Days 1 through 14 of a 28-day cycle. Part D: Participants received 200 mg and 300 mg of LY2228820 in combination with tamoxifen. |
| Name | Type | Description |
|---|---|---|
| LY2228820 | DRUG | Administered Orally |
| Carboplatin | DRUG | Administered IV |
| Placebo | DRUG | Administered Orally |
| Gemcitabine | DRUG | Administered IV |
| Midazolam | DRUG | - |
| Tamoxifen | DRUG | - |
Inclusion Criteria: * Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer * Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment * Are able to swallow tablets * Have given written in...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
LY2228820 is an investigational small molecule being studied for the treatment of advanced cancer and recurrent epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers. It is in Phase 1 clinical development and is not yet approved by the FDA.
LY2228820 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The drug is currently in Phase 1 clinical trials for oncology indications.
LY2228820 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy.
LY2228820 has been studied in two completed Phase 1 trials. NCT01393990 enrolled 89 participants with advanced cancer in the United States. NCT01663857 enrolled 118 female participants with recurrent ovarian, fallopian tube, or primary peritoneal cancer across the United States, Australia, Belgium, and Germany.
LY2228820 is also known as ralimetinib. It is a small molecule drug candidate developed by Eli Lilly and Company for oncology indications, including advanced cancer and epithelial ovarian cancer.