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 : Recruiting
First Posted : April 6, 2017
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Neutropenia||Drug: Plinabulin Drug: Pegfilgrastim Other: Saline Placebo Other: D5W Placebo||Phase 3|
This is a multicenter, double-blind, randomized study. Approximately 190 patients will be enrolled in this study.
All patients will receive docetaxel at a dose of 75 mg/m2. Pn Phase 3, patients with one of the following will be enrolled: advanced or metastatic breast cancer, who have failed ≥ 1 but < 5 prior lines of chemotherapy; locally advanced or metastatic NSCLC after platinum therapy failure; or hormone refractory (androgen independent) metastatic prostate cancer.
The eligibility of all patients will be determined during a 28-day screening period.
Approximately 150 patients are planned to be enrolled in the Phase 3 with one of the following diagnosis: advanced or metastatic breast cancer, who have failed ≥ 1 but < 5 prior lines of chemotherapy; locally advanced or metastatic NSCLC after platinum therapy failure; or hormone refractory (androgen independent) metastatic prostate cancer. Each eligible patient will be stratified according to his or her diagnosis (advanced or metastatic breast cancer, NSCLC, or HRPC). Patients will be randomly assigned with equal probability (1:1 ratio) or 75:75, with the arm designation and planned intervention as follows:
Arm 1: Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin
Arm 2: Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim
In order to facilitate balanced treatment arms with respect to cancer type, once either arm reaches at least 1/3 (of total) of patients with that cancer type, it will be closed to that cancer type and enrollment will continue for patients with the other cancer types, up to the planned maximum number of patients.
Data from all patients receiving the RP3D plinabulin dose in Phase 2 and Phase 3 will not be pooled for assessing the primary and secondary study endpoints, but analyzed separately.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 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.
|Primary Purpose:||Supportive Care|
|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 :||June 1, 2020|
|Estimated Study Completion Date :||July 15, 2020|
Active Comparator: 0.6 ml Pegfilgrastim + D5W placebo
0.6 ml Pegfilgrastim and 250 ml D5W 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: 40 mg Plinabulin + saline placebo
40 mg Plinabulin and 0.6 ml saline 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)
- 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)
- 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
- AUC using the trapezoidal quadrature method for bone pain [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]based on the pain score from the patient bone pain scale from Day 1 through Day 8
- Change in estimated mean bone pain score [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]Change in estimated mean bone pain score from pre-dose Day 1 through Day 8
- Proportion of patients with thrombocytopenia [ Time Frame: Up to 84 days ]Proportion of patients with thrombocytopenia (all grade) during 4 cycles
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
|Contact: Ramon Mohanlal, MD, PhDfirstname.lastname@example.org|
|Contact: Ilda Boholli, MPHemail@example.com|
|Principal Investigator:||Douglas W. Blayney, MD||Stanford University School of Medicine - Cancer Institute|