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Also known as LY573636, LY573636-sodium
tasisulam · 9 trials · 11 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.
Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.
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.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during the first 6-week cycle of treatment. DLT is an adverse event (AE) that is likely related to study drug or combination and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 3.0) Grade (Gr) 4 neutropenia lasting ≥5 days; Gr 4 neutropenia with fever; Gr 4 thrombocytopenia; Gr ≥3 thrombocytopenia with bleeding; Gr ≥3 nonhematologic toxicity (excluding controllable nausea/vomiting or diarrhea and alopecia); Gr 3 electrolyte toxicity that is not resolved with standard treatments; Gr ≥3 elevated hepatic enzyme abnormalities in the setting of preexisting hepatic metastasis may not be considered a DLT; a DLT can be declared if a participant experiences increasing toxicity during treatment.
| Arm | Type | Description |
|---|---|---|
| LY573636-sodium | EXPERIMENTAL | - |
| LY573636 | EXPERIMENTAL | - |
| Tasisulam | EXPERIMENTAL | - |
| LY573636 + Liposomal Doxorubicin | EXPERIMENTAL | - |
| LY573636 +sunitinib | 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 |
| tasisulam | DRUG | Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant 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. |
| Drug: LY573636-sodium | DRUG | Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle. Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses. Participants may continue on treatment until clinical or objective disease progression. |
| Sunitinib | DRUG | 37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle. Participants may continue on treatment until clinical or objective disease progression. |
| 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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Tasisulam is an investigational small molecule being studied for the treatment of metastatic melanoma, a form of skin cancer that has spread to other parts of the body. It was evaluated in a Phase 2 clinical trial in participants with malignant melanoma.
Tasisulam is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company sponsored the clinical trial of tasisulam in metastatic melanoma.
Tasisulam is in Phase 2 clinical development. It has completed a Phase 2 study in metastatic melanoma, but it is still investigational and has not been approved by regulatory authorities. Its development status is based on the completed trial data.
Tasisulam has been studied in one completed Phase 2 clinical trial, identified as NCT00383292, titled "A Study of Tasisulam in Treating Participants With Malignant Melanoma." The trial enrolled 130 participants with metastatic melanoma and was conducted in the United States and Australia.
Tasisulam is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial in metastatic melanoma, but it remains in clinical development and has not received approval from the U.S. Food and Drug Administration or other regulatory agencies.