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RAD001 · 2 trials · 4 indications
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.
| Arm | Type | Description |
|---|---|---|
| Sorafenib and RAD001 | EXPERIMENTAL | * Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have neuroendocrine tumors, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant will be given will depend on the number of participants who have been enrolled in the study. * Each treatment cycle lasts 28 days. Participants will take RAD001 orally once a day in the morning. Participants will take sorafenib orally twice daily. * Participants will remain on this research study as long as they continue to benefit from the study medications. |
| RAD001 and Sorafenib | EXPERIMENTAL | RAD001 and Sorafenib |
| Name | Type | Description |
|---|---|---|
| Sorafenib | DRUG | Taken orally twice daily |
| RAD001 | DRUG | Taken orally once daily in the morning |
Inclusion Criteria: * Locally unresectable or metastatic neuroendocrine tumor (carcinoid tumor or pancreatic neuroendocrine tumor). Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroen...
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RAD001 is an investigational small molecule being studied for the treatment of advanced kidney cancer and advanced neuroendocrine tumors, including carcinoid tumors and pancreatic neuroendocrine tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.
RAD001 is a small molecule that targets the mTOR pathway, which is involved in cell growth and proliferation. By inhibiting this pathway, RAD001 aims to slow or stop the growth of cancer cells in conditions like kidney cancer and neuroendocrine tumors.
RAD001 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical trials for oncology indications.
RAD001 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in kidney cancer and one in neuroendocrine tumors, and is not yet FDA approved. The drug remains investigational and is still being evaluated for safety and effectiveness.
RAD001 has been studied in two completed Phase 1 trials: NCT00392821, which evaluated sorafenib and RAD001 in advanced kidney cancer with 78 participants, and NCT00942682, which tested sorafenib with RAD001 in advanced neuroendocrine tumors with 21 participants. Both trials were conducted in the United States.
RAD001 is an investigational drug being developed by Bayer AG for kidney cancer and neuroendocrine tumors. It is not the same as everolimus, which is a different mTOR inhibitor. RAD001 is still in Phase 1 clinical trials and has not been approved for any indication.