Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Rare Diseases

Pain

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Docetaxel

Lenograstim

Diketopiperazines

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).

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.

Pegfilgrastim

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

Saline Placebo

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

D5W Placebo

Douglas W. Blayney, MD

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\*

Arm 1: Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin

Arm 2: Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim

Plinabulin and pegfilgrastim are each masked using a double-dummy design in phase 3.

Docetaxel administration is not masked.

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

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)

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

Change in estimated mean bone pain score from pre-dose Day 1 through Day 8

Maximum decrease from baseline (prior to Cycle 1 docetaxel dose)

Platelet count at least 30% change from baseline at any time during Cycle 1

Proportion of patients with neutrophil-to-lymphocyte ratio (NLR) \> 5 from Day 7 through Day 15

Proportion of patients with thrombocytopenia (all grade) during 4 cycles

Grade 4 neutropenia (ANC \< 0.5 x 10\^9/L)

Covance

ICON plc

BeyondSpring Pharmaceuticals Inc.

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Taxane

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Phase 3:TAC + Pegfilgrastim (6 mg)+ D5W placebo

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

Phase 3: TAC+ Plinabulin (40 mg) + Pegfilgrastim (6 mg)

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.

Docetaxel, doxorubicin, and cyclophosphamide (TAC)

Douglas Blayney, M.D.

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.

This is a multi-center randomized study, double-blind phase 3 trial. Approximately 222 patients are planned to be enrolled in Phase 3.

Docetaxel, doxorubicin, and cyclophosphamide (TAC) will be used as the chemotherapy in this study. These agents are among the most active and commonly used chemotherapeutic agents employed for treating patients with breast carcinoma. In particular, TAC chemotherapy has been used for the adjuvant treatment of HER2 negative early breast cancer patients with node positive disease as well as for node negative breast cancer patients who have a high risk of recurrence.

Plinabulin is a novel small molecule that is being developed for the mitigation of chemotherapy-induced neutropenia. Administered by IV infusion on the same day of (approximately 1 hour after) chemotherapy (TAC), plinabulin will be given in a single dose per cycle. Plinabulin is being studied to see if it is a convenient alternative to G-CSF, pegfilgrastim, for the prevention of chemotherapy-induced neutropenia.

In this trial, treatment will be double blinded, approximately 222 patients with breast cancer are expected to be enrolled. Patients are randomly assigned to one of the treatment arms, with 111 patients enrolled in each arm, with the arm designation and planned intervention as follows:

Arm 1: TAC + pegfilgrastim (6.0 mg) + placebo matching plinabulin.

Arm 2: TAC + pegfilgrastim (6.0 mg) + plinabulin (40 mg).

Cycles 1 to 4 will consist of TAC (or TC for Cycles 2 to 4) administered IV on Day 1 every 21 days. Patients will receive a single dose of plinabulin or placebo IV over 30 minutes (±5 minutes) in a double blinded manner, 30 minutes after the end of the TAC (or TC for Cycles 2 to 4) infusion. On Day 2 of each cycle (≥24 hours after completing chemotherapy), all patients will receive a single dose of pegfilgrastim (6.0 mg).

The long-term safety follow-up through patients contacts by phone calls, letters or electronic means; or medical records reviews will be conducted to all subjects approximately every 6 months up to 5 years to monitor long term safety of plinabulin.

Plinabulin is masked using a double-dummy design. Docetaxel/Doxorubicin/Cyclophasphamide administration is not masked.

Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia

A Phase 3, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in the Prevention of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2)

DSN is defined as Days of Grade 4 Neutropenia (ANC less than 0.5 X 109/L)

ANC less than 1 x 109/L and above 0.5x 109/L is defined as grade 3 neutropenia. ANC less than 0.5 X 109/L is defined as grade 4 neutropenia.

To evaluate the effect of Plinabulin related to DSN within 15 days

Record the bone pain score from the numerical rating scale (NRS)

Composite risks includes infection, FN, hospitalization, significant disability, life threatening and death

Assess the percentage of patients with RDI \< 85%

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3	NCT03102606	Chemotherapy-in...	Plinabulin Pegfilgrastim Saline Placebo D5W Placebo	18 Years -	BeyondSpring Pharmaceuticals Inc.
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia	NCT03294577	Chemotherapy-in...	Pegfilgrastim Plinabulin D5W Placebo Docetaxel, doxo...	18 Years -	BeyondSpring Pharmaceuticals Inc.
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3	NCT03102606	Chemotherapy-in...	Plinabulin Pegfilgrastim Saline Placebo D5W Placebo	18 Years -	BeyondSpring Pharmaceuticals Inc.

Spots Global Cancer Trial Database for d5w placebo

Every month we try and update this database with for d5w placebo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for d5w placebo

Every month we try and update this database with for d5w placebo cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for d5w placebo cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.