Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Cā¦ (NCT03102606) | Clinical Trial Compass
CompletedPhase 3
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
United States, China105 participantsStarted 2018-05-29
Plain-language summary
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\*
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. At least ā„ 18 years of age (male or female) at the time of signing the informed consent form.
ā. ECOG performance status of 0 to 1.
ā. Patients with:
ā. Pathology confirmation of cancer is required.
ā. Patients with ā„ 1 of the following risk factors, at the initiation of docetaxel chemotherapy, that would require neutropenia prophylaxis per National Comprehensive Cancer Network (NCCN) guidelines (version 2, 2016):
ā. Life expectancy of 3 months or more.
ā. The following laboratory results assessed within 14 days prior to study drug administration:
ā. Prothrombin time (PT)/International Normalized Ratio (INR) ā¤ 1.5 Ć upper limit of normal (ULN), activated partial thromboplastin time (PTT) ā¤ 1.5 Ć ULN, based on central laboratory results.
Exclusion criteria
ā. History of myelogenous leukemia, myelodysplastic syndrome or concomitant sickle cell disease.
ā. Received chemotherapy within 4 weeks prior to the first dose of study drug.
ā. Received prior docetaxel treatment, except adjuvant docetaxel given \> 1 year prior to first dose of study drug
ā. Phase 3 only: Received \>/= 5 lines of cytotoxic chemotherapy for advanced or metastatic breast cancer (adjuvant chemotherapy will count as one line of chemotherapy, and any hormonal or biological, non conjugate therapy \[e.g., trastuzumab\] will not count as a line of therapy).
ā. Current use of strong cytochrome P450 (CYP) 3A4 inhibitors, within 3 days of the first administration of study drug, and 7 days after treatment with taxanes OR requires use of strong CYP3A4 inhibitors
ā. 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 CTCAE (v4.03) treatment emergent AEs.
ā. Receiving any concurrent anticancer therapies (except continued hormonal treatment).
ā. Received a prior bone marrow or stem cell transplant.