Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia (NCT03294577) | Clinical Trial Compass
UnknownPhase 3
Plinabulin vs. Pegfilgrastim in Prevention of TAC Induced Neutropenia
China221 participantsStarted 2019-10-23
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Women who are at least 18 years of age at the time of signing the informed consent form.
✓. In the opinion of their treating oncology investigator, are candidates for at least 4 cycles of chemotherapy with TAC (docetaxel, doxorubicin, \& cyclophosphamide).
✓. Patients who are candidates for adjuvant or neoadjuvant TAC will meet all of the following criteria:
✓. Pathological confirmation of cancer is required.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Have life expectancy of 3 months or more.
✓. 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)
✓. Prothrombin time (PT) and International Normalized Ratio (INR) ≤1.5 × ULN, activated partial thromboplastin time (PTT) ≤1.5 × ULN, based on central laboratory results.
Exclusion criteria
✕. History of myelogenous leukemia, myelodysplastic syndrome, or sickle cell disease.
✕. 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.
What they're measuring
1
Percentage of patients with Duration of Severe Neutropenia (DSN) =0
Timeframe: Duration of Grade 4 neutropenia assessed during the first cycle (21 days)
. 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).
✕. Receiving any concurrent anticancer therapies (including concomitant anti-HER2/neu agents such as trastuzumab \[Herceptin®\], trastuzumab emtansine \[TDM 1, Kadcyla®\], pertuzumab \[Perjeta®\], lapatinib \[Tykerb®\]).
✕. Received a prior bone marrow or stem cell transplant.
✕. Have a co-existing active infection or received systemic anti-infective treatment within 72 hours before the first dose of study drug.
✕. Concurrent or prior radiation therapy within 4 weeks before the first dose of study drug.
✕. Chronic use of filgrastim, pegfilgrastim, or any bioequivalent (biosimilar) for severe chronic neutropenia or other chronic neutropenia syndrome.