Last updated on March 2020

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


Brief description of study

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, 5, 6, 7, 8, 9, 10, 15.

Detailed Study Description

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.

Clinical Study Identifier: NCT03102606

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Recruitment Status: Open


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