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

NCT03102606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-08-29

Study results available
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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; 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\*

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

DRUG

Plinabulin

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).

DRUG

Pegfilgrastim

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

Saline Placebo

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

OTHER

D5W Placebo

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • ICON plc

    collaborator INDUSTRY

  • BeyondSpring Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas W. Blayney, MD · Stanford University School of Medicine - Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2018-12-12
Completion
2021-02-08
FDA Drug
Yes

Countries

  • United States
  • China
  • Russia
  • Ukraine

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102606 on ClinicalTrials.gov