Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03102606 | Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 | PHASE3 | COMPLETED | 105 | — | — | May 29, 2018 | Feb 8, 2021 | Aug 29, 2024 | 18 | United States, China +2 |
| NCT04227990 | Plinabulin iv Solution in Prevention of TAC Induced Neutropenia | PHASE2 | COMPLETED | 115 | — | — | Nov 27, 2017 | Jan 3, 2019 | Jan 18, 2020 | 11 | China, Ukraine |
| NCT04345900 | Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2 | PHASE2 | COMPLETED | 55 | — | — | Apr 5, 2017 | Apr 20, 2018 | May 16, 2024 | 19 | United States, China +2 |
Duration of severe neutropenia (ANC \< 0.5 × 109/L)
Duration of Grade 4 neutropenia (ANC \< 0.5 × 109/L)
| Arm | Type | Description |
|---|---|---|
| Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin | ACTIVE_COMPARATOR | Arm 1 |
| Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim | EXPERIMENTAL | Arm 2 |
| TAC + Pegfilgrastim (6 mg) | ACTIVE_COMPARATOR | - |
| TAC + Plinabulin 10 mg/m^2 | EXPERIMENTAL | - |
| TAC + Plinabulin 20 mg/m^2 | EXPERIMENTAL | - |
| TAC + Plinabulin 30 mg/m^2 | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (1.5 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (3 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (6 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| 20 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin |
| 10 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin |
| 5 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin |
| 6 mg Pegfilgrastim | ACTIVE_COMPARATOR | 75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim |
| Name | Type | Description |
|---|---|---|
| Plinabulin | DRUG | Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes). |
| Pegfilgrastim | DRUG | PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow. |
| Saline Placebo | OTHER | Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration |
| D5W Placebo | OTHER | Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W |
| Docetaxel, doxorubicin, and cyclophosphamide (TAC) | DRUG | Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent. |
Inclusion Criteria: 1. At least ≥ 18 years of age (male or female) at the time of signing the informed consent form. 2. ECOG performance status of 0 to 1. 3. Patients with: Phase 2 only: • Advanced or metastatic NSCLC failing platinum-based therapy Phase 3 only: * Advanced or metasta...