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Docetaxel

Lenograstim

Diketopiperazines

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).

Plinabulin

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.

Pegfilgrastim

Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration

Saline Placebo

Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W

D5W Placebo

Douglas W. Blayney, MD

To assess Duration of Severe Neutropenia (DSN) in treatment Cycle 1 in patients with advanced or metastatic breast cancer, who have failed \>/= 1 but \< 5 prior lines of chemotherapy; locally advanced or metastatic non small cell lung cancer (NSCLC) after platinum therapy failure; or hormone refractory (androgen independent) metastatic prostate cancer treated with docetaxel (75 mg/m2) + plinabulin (40 mg) versus docetaxel (75 mg/m2) + pegfilgrastim (6 mg). Neutrophils count will be assessed at baseline; Pre dose during Cycle 1, Day 1, 2, 6, 7, 8, 9, 10, 15.

\*Study is officially closed on 08 Feb 2021\*

Arm 1: Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin

Arm 2: Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim

Plinabulin and pegfilgrastim are each masked using a double-dummy design in phase 3.

Docetaxel administration is not masked.

Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3

A Phase 3, Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy (Protective 1)

Duration of Grade 4 neutropenia (ANC \< 0.5 × 109/L)

Change in estimated mean bone pain score from pre-dose Day 1 through Day 8

Maximum decrease from baseline (prior to Cycle 1 docetaxel dose)

Platelet count at least 30% change from baseline at any time during Cycle 1

Proportion of patients with neutrophil-to-lymphocyte ratio (NLR) \> 5 from Day 7 through Day 15

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3	NCT03102606	Chemotherapy-in...	Plinabulin Pegfilgrastim Saline Placebo D5W Placebo	18 Years -	BeyondSpring Pharmaceuticals Inc.
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3	NCT03102606	Chemotherapy-in...	Plinabulin Pegfilgrastim Saline Placebo D5W Placebo	18 Years -	BeyondSpring Pharmaceuticals Inc.

Spots Global Cancer Trial Database for duration of severe neutropenia