Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LDE225+gemcitabine · 1 trial · 1 indication
Dose limiting toxicities that occur during the first 8 weeks (56 days) of treatment with LDE225+gemcitabine. Dose limiting toxicity is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that meets study specific criteria.
| Arm | Type | Description |
|---|---|---|
| LDE225+gemcitabine | EXPERIMENTAL | Increasing doses of LDE225 (from 400 mg) once a day + 1000 mg/m2 of gemcitabine on days 1, 8 and 15 of every 28 day cycle. |
| Name | Type | Description |
|---|---|---|
| LDE225+gemcitabine | DRUG | Patients will receive increasing doses of LDE225 (from 400 mg), depending on the cohort they are assigned to, orally once daily and standard doses of gemcitabine (1000 mg/m2) on days 1, 8 and 15 of every 28-day cycle. Patients will receive the study treatment until they progressed, experience unacceptable toxicity, withdraw from the study, or the investigator decides it is in their best interest to discontinue the study treatment. |
Inclusion Criteria: * Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy * Performance status of 0 or 1 per WHO classification * Adequate hematologic , renal and liver function * Adequate blood creatin...
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LDE225 is an investigational small molecule being studied in oncology. Clinical trials have evaluated it in advanced solid tumors, including metastatic breast cancer, pancreatic adenocarcinoma, colorectal cancer, glioblastoma, gastric cancer, and hepatocellular carcinoma, as well as in acute leukemias. It has also been studied in combination with other agents for advanced cancers.
LDE225 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis has sponsored clinical trials of LDE225 across multiple cancer types, including advanced solid tumors and acute leukemias.
LDE225 has completed Phase 1 and Phase 2 clinical trials. The trials listed include Phase 1 dose escalation and combination studies, as well as a Phase 2 study in relapsed or refractory acute leukemia. All listed trials are completed, and LDE225 remains an investigational agent in clinical development.
LDE225 has been studied in several completed trials, including NCT01576666, a Phase 1 dose escalation study in advanced solid tumors; NCT01826214, a Phase 2 study in relapsed or refractory acute leukemia; NCT02027376, a Phase 1 study with docetaxel in triple negative breast cancer; and NCT02151864, a Phase 1 study in hepatocellular carcinoma with cirrhosis.
LDE225 is a small molecule that targets the Hedgehog signaling pathway. It is being investigated for its potential role in treating cancers where this pathway is active, including basal cell carcinoma and other solid tumors. The drug is designed to inhibit this pathway to potentially slow tumor growth.
Yes, LDE225 is also known as sonidegib. In clinical trials, it has been referred to by both names, such as in the study of LDE225 (sonidegib) in combination with docetaxel for advanced breast cancer. This alternative name is used interchangeably in research contexts.