Clinical Trial: Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2/3, Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppres

Brief Summary: 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; advanced or metastatic non-small cell lung cancer (NSCLC) after failing platinum based therapy; or hormone refractory (androgen independent) metastatic prostate cancer treated with docetaxel (75 mg/m2) + plinabulin (RP3D) 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 Summary:

This is a multicenter, double-blind, randomized study with a phase 2 portion and a phase 3 portion. Approximately 190 patients will be enrolled in this study.

All patients will receive docetaxel at a dose of 75 mg/m2.

In Phase 2, patients only with advanced or metastatic NSCLC after failing platinum based therapy will be enrolled.

In 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; advanced or metastatic NSCLC after failing platinum based therapy; or hormone refractory (androgen independent) metastatic prostate cancer.

The eligibility of all patients will be determined during a 28-day screening period.

Phase 2:

Approximately 40 patients with advanced and metastatic NSCLC will be enrolled. Patients are randomly assigned, with 10 patients enrolled in each arm, 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 (20 mg/m2) + placebo matching pegfilgrastim

Arm 3: Docetaxel (75 mg/m2) + plinabulin (10 mg/m2) + placebo matching pegfilgrastim

Arm 4: Docetaxel (75 mg/m2) + plinabulin (5 mg/m2) + placebo matching pegfilgrastim

The study will be temporarily closed to enrollment when 40 patients have been enrolled and completed at least 1 treatment
Sponsor: BeyondSpring Pharmaceuticals Inc.

Current Primary Outcome: Duration of Severe Neutropenia (DSN) [ Time Frame: Duration of Grade 4 neutropenia assessed once within the first 21-day cycle ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Grade 4 neutropenia [ Time Frame: Duration of the study treatment period (84 days) ]
    Grade 4 neutropenia (ANC < 0.5 × 109/L)
  • Incidence of Febrile Neutropenia (FN) [ Time Frame: Duration of the study treatment period (84 days) ]
    FN = ANC < 0.5 × 10**9/L and body temperature ≥ 38.3°C
  • Health-related QoL questionnaire evaluated with EORTC QLQ-C30 [ Time Frame: Duration of the study treatment period (84 days) ]
    Quality of Life Measurement
  • Neutrophil Nadir [ Time Frame: The neutrophil nadir is identified once during the first 21-day cycle ]
    Minimum neutrophil count during Cycle 1
  • Incidence of docetaxel treatment modification [ Time Frame: Duration of the study treatment period (84) days ]
    Modification of docetaxel administration
  • Bone pain [ Time Frame: Duration of the study treatment period (84 days) ]
    Bone pain inventory - Short Form
  • Incidence of Hospitalizations due to FN [ Time Frame: Duration of the study treatment period (84 days) ]
    FN = ANC < 0.5 × 10**9/L and body temperature ≥ 38.3°C
  • Incidence of documented infections [ Time Frame: Duration of the study treatment period (84 days) ]
    Percentage of patients in with documented infections


Original Secondary Outcome: Same as current

Information By: BeyondSpring Pharmaceuticals Inc.

Dates:
Date Received: March 6, 2017
Date Started: March 13, 2017
Date Completion: June 15, 2018
Last Updated: March 30, 2017
Last Verified: November 2016