Approval Probability
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tasisulam · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Tasisulam | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV) * Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counte...
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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.