Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Copanlisib
Copanlisib+ Refametinib · 3 trials · 1 indication
Cmax: maximum drug concentration in plasma after single dose administration
Cmax/D: Cmax divided by total dose in \[mg\]
tmax: time to reach maximum drug concentration in plasma after single (first) dose
AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
AUC: area under the plasma concentration vs time curve from zero to infinity
AUC/D: AUC divided by total dose in \[mg\]
AUC(0-25): area under the plasma concentration vs time curve from zero to 25 h p.a.
AE,ur(0-25): amount of drug excreted via urine during the collection interval 0 - 25 h
| Arm | Type | Description |
|---|---|---|
| Copanlisib (BAY80-6946) | EXPERIMENTAL | The treatment of consists of repetitive cycles, each over 4 weeks. It continues until disease progression or limiting toxicity. If paclitaxel is discontinued for toxicity, BAY80-6946 may continue at the discretion of the investigator if a clinical benefit (response or stable disease for 6 months) is noted. |
| Arm 1 | EXPERIMENTAL | - |
| Copanlisib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Paclitaxel (80 mg/m2 in Cohort 1, 2 and 3, 90 mg/m2 in Cohort 4) as 60-minute iv infusion once weekly on Days 1, 8, 15 and 22 (Day 22 in Cohort 1, 2 and 3 only) in 28-day cycles * The following intravenous premedications are required 30 to 60 minutes before paclitaxel infusion: Dexamethasone (10 mg), diphenhydramine (50 mg) and either cimetidine (300 mg) or ranitidine (50 mg) * Alternatively, for premedications other than dexamethasone, the standard institutional regimen is permitted. |
| Copanlisib (BAY80-6946) | DRUG | BAY80-6946 (0.6 mg/kg in Cohort 1, 0.8 mg/kg in Cohort 2, 3 and 4) as 60-minute iv infusion once weekly on Days 2, 9, 16 and 23 (Day 23 in Cohort 1, 2 and 3 only) in 28-day cycles |
| Copanlisib + Refametinib (BAY86-9766) | DRUG | Copanlisib will be administered as an IV infusion weekly for 3 weeks in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 4 of Cycle 1. |
| Copanlisib (Aliqopa, BAY80-6946) | DRUG | BAY80-6946 given IV over 1 hour every week for three weeks with a one week break until progression or unacceptable toxicities develop. |
Inclusion Criteria: * Subjects must have defined tumor classification (ie, TNBC, HER2+ or Luminal) for enrollment. If tumor classification is not available the subject cannot be enrolled. Tumor classification can be based on analysis of archived tumor tissue, or analysis of tumor tissue collected a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
Copanlisib is an investigational small molecule being studied for the treatment of lymphoma, including non-Hodgkin lymphoma and marginal zone lymphoma, as well as other neoplasms. It is also being evaluated in healthy volunteers for research purposes. The drug is in Phase 2 clinical development for these oncology indications.
Copanlisib targets PI3K, which stands for phosphoinositide 3-kinase. It belongs to the -lisib class of drugs, which are PI3K inhibitors. By inhibiting PI3K, Copanlisib is designed to interfere with signaling pathways involved in cancer cell growth and survival.
Copanlisib is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of Copanlisib in various cancer indications.
Copanlisib is currently in Phase 2 clinical development. It has completed Phase 1 trials and is being evaluated in an active Phase 2 study for marginal zone lymphoma. The drug is investigational and has not been approved by regulatory authorities for any indication.
Copanlisib has been studied in several clinical trials. NCT01392521 is a completed Phase 1 study combining Copanlisib with refametinib in advanced cancer. NCT02253420 is a completed Phase 1 drug interaction and cardiovascular safety study. NCT03474744 is an active Phase 2 trial of Copanlisib with rituximab in marginal zone lymphoma. NCT03735628 is a completed Phase 1 study with nivolumab in advanced solid tumors.
Yes, Copanlisib is also known as BAY80-6946. This alternative name appears in clinical trial records, such as NCT02253420, which is titled 'COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study.' Researchers and investors may encounter either name when reviewing the drug's development history.