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Also known as roniciclib (BAY 1000394)
roniciclib · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Roniciclib + Itraconazole | EXPERIMENTAL | Pharmacokinetics and safety in patients with advanced solid tumor |
| Arm 1 | EXPERIMENTAL | Open label non-randomized non-controlled mass balance study in Cycle 1 |
| Arm 2 | EXPERIMENTAL | Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles |
| Roniciclib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Roniciclib (BAY 1000394) | DRUG | Part 1 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 mg Cycle 1 Day 6: Single dose 2.5 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 or 5 mg (based on Part 1 data) Cycle 1 Day 6: Single dose 2.5 or 5 mg (based on part 1 data) Part 1 \& Part 2 Cycle 2 and subsequent 21-day cycles: Day 1-3 of each cycle: 5 mg bid Day 4-7 of each cycle: no dose |
| Itraconazole (Sporanox) | DRUG | Part 1 \& Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd |
| Roniciclib (BAY1000394) | DRUG | Oral administration twice daily in a 3 days on / 4 days off schedule. Starting dose will be 0.3 mg corresponding to approximately 0.005 mg/kg and dose will be escalated dependent on any dose limiting toxicities. |
Inclusion Criteria: * Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be re...
Roniciclib is an investigational small molecule being studied in oncology for the treatment of medical oncology and neoplasms, including advanced malignancies. It is not approved for any indication and remains in clinical development.
Roniciclib targets cyclin-dependent kinases CDK1, CDK2, CDK4, CDK5, CDK6, and CDK7. It acts as an inhibitor of these kinases, which are involved in cell cycle regulation and transcription.
Roniciclib is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY.
Roniciclib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency for any indication.
Roniciclib has been evaluated in completed Phase 1 trials, including NCT02457351, a drug-drug interaction study in Canada; NCT02390154, a mass balance study in Hungary; and NCT01188252, a dose-finding study in the United States, France, and Germany.
Yes, roniciclib is also known as BAY 1000394 or BAY1000394. These names refer to the same investigational compound developed by Bayer.