Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RDEA119 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| RDEA119 with Sorafenib | EXPERIMENTAL | Total daily doses of RDEA119 from 10 mg/day to 100 mg/day and sorafenib from 400 mg/day to 800 mg/day. |
| Arm 1 | EXPERIMENTAL | In the dose escalation phase, subjects will receive a single oral dose of RDEA119 on Day 1, wait 1 week, then begin a 28-day course of daily continuous dosing of RDEA119. In the expanded MTD phase, subjects will receive RDEA119 once or twice a day beginning on Day 1, and begin a 28-day course of continuous dosing at that time. |
| Name | Type | Description |
|---|---|---|
| RDEA119 | DRUG | Total daily doses of RDEA119 from 10 mg/day to 100 mg/day |
| Sorafenib | DRUG | Total daily doses of sorafenib from 400 mg/day to 800 mg/day. |
Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Histological or cytological confirmed diagnosis of a solid tumor. In the dose escalation phase, the tumor must be unresectable and locally advanced, or metastatic, and either no proven effective therapy exis...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
RDEA119 is an investigational small molecule being studied for the treatment of advanced cancer. It is in Phase 1 clinical development and has been evaluated in two completed trials enrolling a total of 131 patients with advanced cancer. It is not approved by the FDA and remains in clinical development.
RDEA119 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 1 clinical trials for advanced cancer, with two completed studies.
RDEA119 is in Phase 1 clinical development. It has completed two Phase 1 trials for advanced cancer, with a total enrollment of 131 patients. The drug is investigational and has not been approved by the FDA.
RDEA119 has been studied in two completed Phase 1 trials: NCT00610194, a dose-escalation pharmacokinetic and pharmacodynamic trial in advanced cancer patients, and NCT00785226, a combination dose escalation study with sorafenib. Both trials enrolled patients with advanced cancer.
No, RDEA119 is not the same as sorafenib. RDEA119 is a separate investigational drug being developed by Bayer AG. In one clinical trial, NCT00785226, RDEA119 was studied in combination with sorafenib, but they are distinct agents.