Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY573636 · 7 trials · 9 indications
Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Objective response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death from study disease. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.0). PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which is corrected for the participant's predose albumin to identify the albumin-corrected exposure range of LY 573636 when combined with liposomal doxorubicin. MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) in the first 28-day cycle of treatment. DLT is an adverse event (AE) that is likely related to the study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity; Gr 3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments. Those who enter the study with Gr 2 hepatic enzyme abnormalities, DLT for an isolated Gr 3 hepatic enzyme abnormality is determined by investigators; a DLT can be declared if a participant experiences increasing toxicity during treatment.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose at which no more than 1 of 6 participants experienced a dose-limiting toxicity (DLT) and level immediately below that which had ≥2 instances of DLT. A DLT is an adverse event (AE) observed during the first cycle of treatment that is believed to be related to LY573636 and fulfills any of the following: ET only , Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 hematologic toxicity for ≥3 days; For all, ≥Gr 3 nonhematological toxicity except for nausea/vomiting or diarrhea unless it fits the next criteria; ≥Gr 3 nausea, vomiting, or diarrhea that persists \>7 days despite maximal treatment; Gr 3 electrolyte disturbances that persist despite maximal measures; DLT can be declared if a participant experienced increasing toxicity during treatment. The primary outcome measure was not analyzed because the enrollment was stopped early before MTD was reached.
| Arm | Type | Description |
|---|---|---|
| LY573636-sodium | EXPERIMENTAL | - |
| LY573636 | EXPERIMENTAL | - |
| LY573636 + Liposomal Doxorubicin | EXPERIMENTAL | - |
| Experimental: Pemetrexed followed by LY573636 | EXPERIMENTAL | Pemetrexed on Day 1 followed by LY573636 on Day 4 |
| Experimental: LY573636 followed by Pemetrexed | EXPERIMENTAL | LY573636 on Day 1, pemetrexed on Day 4 |
| Experimental: LY573636 and Pemetrexed on Day 1 | EXPERIMENTAL | LY573636 and Pemetrexed on Day 1 |
| Name | Type | Description |
|---|---|---|
| LY573636-sodium | DRUG | Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met |
| Liposomal Doxorubicin | DRUG | 40 mg/m² on Day 1, given intravenously of each 28-day cycle Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met. |
| LY573636 | DRUG | Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid \[350 micrograms (µg) to 1000 µg orally, daily\], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone \[4 milligrams (mg) orally, twice daily or equivalent\]. |
| Pemetrexed | DRUG | 375 to 500 milligrams per square meter (mg/m\^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days). Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met. Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent). |
Inclusion Criteria: * Received at least 2 or more prior chemotherapy regimens for metastatic breast cancer. * Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. Patients w...
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LY573636 is an investigational small molecule being studied for the treatment of several cancers, including acute myeloid leukemia, solid tumors, breast cancer, non-small-cell lung cancer, ovarian cancer, sarcoma, and soft tissue sarcoma. It is developed by Eli Lilly and Company and is currently in clinical development, though no approval has been granted.
LY573636 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being investigated for its anticancer activity across multiple tumor types, but the exact mechanism of action is not publicly detailed.
LY573636 is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule in the oncology therapeutic area.
LY573636 is in Phase 1 clinical development. It has completed two Phase 2 trials and one Phase 1 trial, but no Phase 3 studies have been initiated. The drug remains investigational and is not approved for any indication.
LY573636 has been studied in several completed trials, including NCT00363766 for non-small-cell lung cancer, NCT00428610 for ovarian cancer, NCT00490451 for soft tissue sarcoma, and NCT00718159 for acute myeloid leukemia and essential thrombocythemia. All trials are completed, with no active studies ongoing.
LY573636 is also known as LY573636-sodium in some clinical trial records. No other alternative names have been reported for this investigational drug.