Chemotherapy-induced Neutropenia Clinical Trial
Official title:
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)
Verified date | January 2021 |
Source | BeyondSpring Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 221 |
Est. completion date | September 25, 2025 |
Est. primary completion date | September 25, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Women who are at least 18 years of age at the time of signing the informed consent form. 2. In the opinion of their treating oncology investigator, are candidates for at least 4 cycles of chemotherapy with TAC (docetaxel, doxorubicin, & cyclophosphamide). 3. Patients who are candidates for adjuvant or neoadjuvant TAC will meet all of the following criteria: - Biopsy-proven, early stage (Stage I and II) and Stage III breast cancer, and - Have had no prior chemotherapy. 4. Pathological confirmation of cancer is required. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Have life expectancy of 3 months or more. 7. Laboratory results provided by the central laboratory within 14 days prior to study drug administration within noted ranges, per study protocol (local laboratories may be accepted on a case by case basis after discussion with the medical monitor; however in this case central laboratories must also be taken within the screening time window) 8. Prothrombin time (PT) and International Normalized Ratio (INR) =1.5 × ULN, activated partial thromboplastin time (PTT) =1.5 × ULN, based on central laboratory results. 9. Women of childbearing potential have a negative pregnancy test at screening. Exclusion Criteria: 1. History of myelogenous leukemia, myelodysplastic syndrome, or sickle cell disease. 2. Use of strong CYP3A4, CYP2D6 or P-glycoprotein (P-gp) inhibitors and inducers, within 14 days of the first administration of study drug and for the duration of the study. 3. Received an investigational agent or tumor vaccine within 2 weeks before the first dose of study drug; patients must have recovered from toxicity of prior treatment and have no >Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) treatment emergent adverse events (TEAE). 4. Receiving any concurrent anticancer therapies (including concomitant anti-HER2/neu agents such as trastuzumab [Herceptin®], trastuzumab emtansine [TDM 1, Kadcyla®], pertuzumab [Perjeta®], lapatinib [Tykerb®]). 5. Received a prior bone marrow or stem cell transplant. 6. Have a co-existing active infection or received systemic anti-infective treatment within 72 hours before the first dose of study drug. 7. Concurrent or prior radiation therapy within 4 weeks before the first dose of study drug. 8. Chronic use of filgrastim, pegfilgrastim, or any bioequivalent (biosimilar) for severe chronic neutropenia or other chronic neutropenia syndrome. 9. Presence of any serious or uncontrolled illness including, but not limited to: uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirements or any other conditions that would preclude the patient from study treatment as per the discretion of the Investigator. 10. Significant cardiovascular history: - Cardiac ventricular dysfunction inhibiting the patient's ability to receive 4 cycles of doxorubicin. - History of myocardial infarction or ischemic heart disease within 1 year (within a window of up to 18 days less than 1 year) before first study drug administration - Uncontrolled arrhythmia - History of congenital QT prolongation - Electrocardiogram (ECG) findings consistent with active ischemic heart disease - New York Heart Association Class III or IV cardiac disease; - Uncontrolled hypertension: blood pressure consistently >150 mm Hg systolic and > 100 mm Hg diastolic in spite of antihypertensive medication 11. History of hemorrhagic diarrhea, inflammatory bowel disease, or active uncontrolled peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable). History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility. 12. Any other active malignancy requiring active therapy. 13. Known human immunodeficiency virus (HIV) seropositivity. 14. Active Hepatitis B virus (HBV) infection which requires antiviral treatment or the patient has detectable Hepatitis B surface Antigen (HBsAg); hepatitis B surface antibody (anti-HBs) without detectable HBsAg does not exclude patients from the study. Hepatitis C infection (Hepatitis C antibody reactive) which requires treatment also excludes patients from the study. 15. Female patient who is pregnant or lactating. 16. Use of prophylactic antibiotics. 17. Unwilling or unable to comply with procedures required in this protocol. 18. History of allergy to any of the study drugs. |
Country | Name | City | State |
---|---|---|---|
China | China-Japan Union Hospital of Jilin University Tumor department of Hematology | Changchun | Jilin |
China | Cancer Center of Guangzhou Medical University | Guangzhou | Guangdong |
China | Cancer Center of Guangzhou Medical University Breast Oncology | Guangzhou | Guangzhou |
China | No. 1 Banshandong Road | Hangzhou | Gongshu District |
China | Harbin Medical University Cancer Hospital | Harbin | Harbin |
China | Liaoning Cancer Hospital & Institute | Shenyang | Shenyang |
China | Fourth Hospital of Hebei Medical University Breast cancer department | Shijiazhuang | Hebei |
Ukraine | Dnipropetrovsk City Multifunctional Hospital #4 Oncology Department | Dnepropetrovsk | |
Ukraine | Prykarpatskiy Regional Oncological Center | Ivano-Frankivs'k | |
Ukraine | Regional Clinical Oncology Center | Kharkiv | |
Ukraine | V.T. Zaycev Institute | Kharkiv | |
Ukraine | Public Institution Kryvyi Rih Oncology Center | Krivoy Bereg | |
Ukraine | Kirovograd Regional Oncological Center | Kropyvnytskyi | |
Ukraine | Hemotherapy Department | Kyiv | |
Ukraine | Kyiv City Clinical Oncological Center | Kyiv | |
Ukraine | Lviv State Oncological Regional | Lviv | |
Ukraine | Odessa regional clinical hospital Thoracic Surgery Department Academician Zabolotnoho | Odessa | |
Ukraine | Zakarpattia Regional Clinical Oncology Center | Uzhgorod | |
Ukraine | Vinnytsya Regional Clinical Oncology Dispensary | Vinnytsia | |
Ukraine | Zaporizhia Regional Clinical Oncology Dispensary | Zaporizhzhya |
Lead Sponsor | Collaborator |
---|---|
BeyondSpring Pharmaceuticals Inc. |
China, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with Duration of Severe Neutropenia (DSN) =0 | DSN is defined as Days of Grade 4 Neutropenia (ANC less than 0.5 X 109/L) | Duration of Grade 4 neutropenia assessed during the first cycle (21 days) | |
Secondary | Mean DSN assessment | DSN is defined as Days of Grade 4 Neutropenia (ANC less than 0.5 X 109/L) | From day 1 to day 8 in first cycle (21 days) | |
Secondary | Mean ANC nadir | record and evaluate the lowest ANC value | Duration of first cycle (21 days) | |
Secondary | Percentage of Patients without grade 3 and grade 4 neutropenia | 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. | Duration of first cycle (21 days) | |
Secondary | Mean DSN assessment within 15 days | To evaluate the effect of Plinabulin related to DSN within 15 days | From day 1 to day 15 in the first cycle (21 days) | |
Secondary | Average change in bone pain | Record the bone pain score from the numerical rating scale (NRS) | From -1 day over the observational period | |
Secondary | Rate of composite risks | Composite risks includes infection, FN, hospitalization, significant disability, life threatening and death | Duration of all 4 cycle (21 days) | |
Secondary | Percentage of patients with relative dose intensity < 85% | Assess the percentage of patients with RDI < 85% | Duration of all 4 cycle (21 days) |
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