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Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia

NCT03294577 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2021-01-15

No results posted yet for this study

Summary

The primary purpose of this study is to compare the percentage of patients with Duration of Severe Neutropenia (DSN) =0 in patients treated with:

Docetaxel, doxorubicin, and cyclophosphamide (TAC) + pegfilgrastim versus Docetaxel, doxorubicin, and cyclophosphamide (TAC) + combination plinabulin/pegfilgrastim

Severe neutropenia is an absolute neutrophil count (ANC) \<0.5 × 10\^9/L.

Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study.

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

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.

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).

OTHER

D5W Placebo

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

DRUG

Docetaxel, doxorubicin, and cyclophosphamide (TAC)

Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent.

Sponsors & Collaborators

  • BeyondSpring Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Blayney, M.D. · Stanford University School of Medicine - Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2020-09-25
Completion
2025-09-25
FDA Drug
Yes

Countries

  • China
  • Ukraine

Study Locations

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Entities

Drugs

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 NCT03294577 on ClinicalTrials.gov