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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 for the treatment of neoplasms and medical oncology conditions. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced malignancies, as part of early-stage clinical trials.
Roniciclib is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational oncology drug.
Roniciclib is currently in Phase 1 clinical development. It is an investigational drug that has not yet received regulatory approval. All completed trials for Roniciclib are Phase 1 studies, which are designed to evaluate the drug's safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
Roniciclib has been studied in three completed Phase 1 clinical trials. These include NCT01188252, a dose-escalation study in patients with advanced malignancies; NCT02390154, a mass balance study; and NCT02457351, a drug-drug interaction study. All trials have been completed, with a total enrollment of 119 patients.
Roniciclib is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has not completed the clinical trials and regulatory review process required for marketing approval. It remains under investigation for the treatment of neoplasms and medical oncology conditions.
Roniciclib is a small molecule being developed for oncology indications. The specific molecular target of Roniciclib has not been disclosed in the available clinical trial information. The drug is being evaluated for its safety and tolerability in patients with advanced malignancies, but its mechanism of action is not specified.