Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neutropenia

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Docetaxel

Chemotherapy with docetaxel and carboplatin followed by Telintra until ANC recovery

Chemotherapy with docetaxel and carboplatin alone

4500 mg orally per day in two divided doses

ezatiostat hydrochloride (Telintra®)

Gail Brown, MD

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.

Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer

Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Receiving First-Line Chemotherapy

Telik

Lenograstim

Adjuvants, Immunologic

Immunologic Factors

Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle

PEG-G-CSF

Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 1 cycle

G-CSF

JaeHong Seo, M.D.

This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.

Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 1 cycles of chemotherapy.

Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

Multi-Center, Randomized, Open, Phase II Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy

Grade 4 neutropenia means the ANC count is less than 500/mm3.

ANC nadir means the lowest point of ANC count.

ANC recovery means the ANC count is more than 2,000/mm3.

Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.

IV antibiotics administration means that antibiotics are administered through intravenous route.

Dong-A ST Co., Ltd.

Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle

Pegteograstim

Ki Woong Sung, MD, PhD

Ki Woong Sung

To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

Pegteograstim in Children With Solid Tumors

Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors

Green Cross Corporation

Samsung Medical Center

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Pain

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Taxane

Alkylating Agents

Diketopiperazines

Immunosuppressive Agents

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)

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

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

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

D5W Placebo

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
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer	NCT00701870	Non-small Cell ...	ezatiostat hydr...	18 Years -	Telik
Study of Telintra for Treatment of Chemotherapy Induced Neutropenia in Patients With Non-Small Cell Lung Cancer	NCT00701870	Non-small Cell ...	ezatiostat hydr...	18 Years -	Telik
Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia	NCT01923545	Chemotherapy In...	PEG-G-CSF G-CSF	18 Years - 70 Years	Dong-A ST Co., Ltd.
Pegteograstim in Children With Solid Tumors	NCT02787876	Chemotherapy In... Pediatric Solid...	Pegteograstim	- 18 Years	Samsung Medical Center
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia	NCT03294577	Chemotherapy-in...	Pegfilgrastim Plinabulin D5W Placebo Docetaxel, doxo...	18 Years -	BeyondSpring Pharmaceuticals Inc.

Spots Global Cancer Trial Database for chemotherapy induced neutropenia