Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RAD001
RAD001+ BEZ235 · 1 trial · 3 indications
The maximum tolerated dose (MTD) and the dose limiting toxicities during the first cycle of treatment
Frequency of DLTs during the first cycle of treatment
Measured by abnormal safety laboratory parameters, changes in electrocardiograms (ECGs), changes in vital signs and changes in physical examination parameters.
| Arm | Type | Description |
|---|---|---|
| RAD001 + BEZ235 | EXPERIMENTAL | Patients will receive first dose of RAD001 at 2.5mg/5mg/10 mg weekly or 2.5mg/5mg daily in combination of BEZ235 at 50 mg/100 mg/200 mg/300 mg/400 mg twice a day. In the initial cohort of the dose finding phase, patients will receive a single 2.5 mg dose of RAD001 on Cycle 1 Day 1 and the combination therapy of RAD001 2.5 mg/week and BEZ235 200 mg bid starting on Cycle 1 Day 8. Dose escalation phase: patients will start RAD001 and BEZ235 on Cycle 1 Day 1 with both study drugs being administered at the center. Dose expansion phase: the first 15 patients enrolled at selected sites will take RAD001 as monotherapy from Day 1 to Day 7 (for PK sampling). The combination therapy of RAD001 and BEZ235 will start on Day 8. All remaining patients will receive the combination therapy of RAD001 and BEZ235 starting on Cycle 1 Day 1. |
| Name | Type | Description |
|---|---|---|
| RAD001 + BEZ235 | DRUG | RAD001 is formulated as tablets of 2.5 mg and 5 mg strength, blistered in units of 10 tablets (for oral use) each. Blisters should be opened only at the time of dministration as the drug is both hygroscopic and light-sensitive. RAD001 should be administered immediately after a meal with a large glass of water. BEZ235 is supplied as 50-mg, 200-mg, 300-mg and 400-mg sachets (for oral use). BEZ235 is packaged in aluminum foil bags. Bags are packaged in a box. Patients will receive RAD001 in combination with BEZ235. |
Inclusion Criteria: * Male and female patients age 18 years or older * In the dose finding phase, patients with histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable * In the dose expansion phase, the enrollment will be limited to patients with: ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
RAD001 is an investigational small molecule being studied in oncology for gastrointestinal stromal tumors, renal cell carcinoma, breast cancer, prostate cancer, carcinoma, and non-small-cell lung carcinoma. It is also being evaluated in other conditions such as tuberous sclerosis complex and prevention of acute rejection in pediatric renal transplant recipients.
RAD001 targets mTOR, a protein that regulates cell growth and proliferation. By inhibiting mTOR, RAD001 is being studied as a potential treatment for various cancers and other conditions.
RAD001 is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 1 clinical development for oncology indications.
RAD001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.
RAD001 has been studied in several clinical trials, including NCT01122199 (RAD001 plus AMG479 for advanced solid tumors), NCT01275222 (everolimus with imatinib for gastrointestinal stromal tumors), NCT01289912 (RAD001 and neurocognition in tuberous sclerosis complex), and NCT01544491 (everolimus in pediatric renal transplant recipients).
Yes, RAD001 is also known as everolimus. Clinical trials listed under the name everolimus, such as NCT01275222 and NCT01544491, are studying the same drug compound.