Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY80-6946 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment A: Gemcitabine-Copanlisib | EXPERIMENTAL | The treatment consists of repetitive cycles, each over 28 days. Treatment continues until disease progression or dose limiting toxicity. If gemcitabine is discontinued for toxicity, Copanlisib may be continued at the discretion of the Investigator if a clinical benefit (response or stable disease for 3 months) is noted. - Hour 0 to 0.5: Gemcitabine (1000 mg/m2 as 30-minute IV infusion) on Days 1, 8 and 15 every 28 days - Hour 1.5 to 2.5: BAY80-6946 (starting dose = 0.6 mg/kg as 60-minute IV infusion, starting 1 hour post completion of gemcitabine infusion) on Days 1, 8 and 15 every 28 days |
| Treatment B: Cisplatin-Gemcitabine-Copanlisib | EXPERIMENTAL | Treatment consists of repetitive 21 day cycles for a maximum of 8 cycles. Treatment continues until disease progression, DLT or completion of 8 cycles. After 8 cycles, gemcitabine and Copanlisib, without cisplatin, may continue at the discretion of the Investigator until disease progression or DLT if a clinical benefit is noted (response or stable disease for 3 months). Treatment is administered on Days 1 and 8 every 21 days as follows: - Hour 0 to 1: Cisplatin IV infusion over 60 min (One liter of 0.9% NaCl including 25 mg/m2 cisplatin, 20 mmol of potassium chloride, and 8 mmol of magnesium sulfate) - Hour 1 to 1.5: IV infusion of 500 ml of 0.9% NaCl over 30 min - Hour 1.5 to 2: Gemcitabine (1000 mg/m2 as 30 min IV infusion) - Hour 3 to 4: Copanlisib IV infusion at the MTD determined in Treatment A over 60 min. \[If Treatment A MTD is not tolerable, further subject enrollment will begin at one Copanlisib Dose Level lower with the cisplatin-gemcitabine doses remaining constant.\] |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Gemcitabine 1000mg/m2 as 30-minutes IV infusion |
| BAY80-6946 | DRUG | Escalated dose starting from 0.6 mg/kg in 100 mL of 0.9% NaCl as 60-minutes IV infusion |
| Cisplatin | DRUG | 1 liter of 0.9% NaCl including 25 mg/m2 cisplatin, 20 mmol of potassium chloride, and 8 nmol of magnesium sulfate over 60 minutes |
| NaCl | DRUG | Infusion of 500 ml of 0.9% NaCl over 30-minutes |
| BAY80-6964 fixed dose | DRUG | BAY80-6946 IV infusion at the maximum tolerated dose determined in Treatment A over 60 min. \[If Treatment A MTD is not tolerable, further subject enrollment will begin at one BAY80-6946 Dose Level lower with the cisplatin-gemcitabine doses remaining constant.\] |
Inclusion Criteria: * Subjects, at least 18 years of age, with advanced or refractory solid tumors in whom gemcitabine (Treatment A) or cisplatin plus gemcitabine (Treatment B) is appropriate medical therapy as determined by the treating physician * Histological or cytological documentation of non-...
| 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 |
BAY80-6946 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can include tumors. It is in Phase 1 clinical development for oncology indications. The drug is not approved and remains under investigation in clinical trials.
BAY80-6946 is a phosphatidylinositol-3-kinase (PI3) inhibitor. It works by inhibiting PI3 kinase, an enzyme involved in cell growth and survival pathways that are often dysregulated in cancer. This mechanism is being evaluated in Phase 1 trials for patients with advanced neoplasms.
BAY80-6946 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development for oncology indications.
BAY80-6946 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, but the drug remains in early-stage clinical testing for the treatment of neoplasms.
BAY80-6946 has been studied in two completed Phase 1 clinical trials. NCT01404390 was a Japanese monotherapy study with 10 participants. NCT01460537 was a US study combining BAY80-6946 with gemcitabine or cisplatin plus gemcitabine in 50 patients with advanced cancer. Both trials enrolled adults with neoplasms.
Yes, BAY80-6946 is also known as copanlisib. In clinical trial NCT01460537, the drug is referred to as the PI3 kinase inhibitor copanlisib. This alternative name is used in research contexts to identify the same investigational compound being developed by Bayer AG.