Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3 (Protective-1)
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|ClinicalTrials.gov Identifier: NCT03102606|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Neutropenia||Drug: Plinabulin Drug: Pegfilgrastim Other: Saline Placebo Other: D5W Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
Plinabulin and pegfilgrastim are each masked using a double-dummy design in phase 3.
Docetaxel administration is not masked.
|Official Title:||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)|
|Actual Study Start Date :||May 29, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||December 15, 2020|
|Active Comparator: Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching 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.
Other: D5W Placebo
Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
|Experimental: Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim||
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).
Other: Saline Placebo
Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
- Duration of Severe Neutropenia (DSN) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Duration of Grade 4 neutropenia (ANC < 0.5 × 109/L)
- Change in estimated mean bone pain score [ Time Frame: Day 1 through 8 in Cycle 1 (each cycle is 21 days) ]Change in estimated mean bone pain score from pre-dose Day 1 through Day 8
- Platelet count in Cycle 1 [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Maximum decrease from baseline (prior to Cycle 1 docetaxel dose)
- Change in Platelet count from baseline in Cycle 1 [ Time Frame: Anytime during Cycle 1 (each cycle is 21 days) ]Platelet count at least 30% change from baseline at any time during Cycle 1
- Proportion of patients with neutrophil-to-lymphocyte ratio (NLR) > 5 [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Proportion of patients with neutrophil-to-lymphocyte ratio (NLR) > 5 from Day 7 through Day 15
- Bands count [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Bands > 0 after Day 7 through Day 15
- Proportion of patients with thrombocytopenia [ Time Frame: Up to 84 days ]Proportion of patients with thrombocytopenia (all grade) during 4 cycles
- Infections [ Time Frame: Cycle 1 to Cycle 4 (each cycle is 21 days) ]Incidence of infections in cycles 1 to 4
- Antibiotic Use [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Incidence of antibiotic use
- Neutropenia [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Grade 4 neutropenia (ANC < 0.5 x 10^9/L)
- Sepsis [ Time Frame: Cycle 1 to Cycle 4 (each cycle is 21 days) ]To assess the incidence of sepsis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102606
|Principal Investigator:||Douglas W. Blayney, MD||Stanford University School of Medicine - Cancer Institute|