Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Cā¦ (NCT04345900) | Clinical Trial Compass
CompletedPhase 2
Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
United States, China55 participantsStarted 2017-04-05
Plain-language summary
To assess the duration of severe neutropenia (DSN) in treatment Cycle 1 in patients treated with docetaxel (75 mg/m2) + plinabulin (5, 10, or 20 mg/m2) or with docetaxel (75 mg/m2) + pegfilgrastim (6 mg). Neutrophils count was to be assessed at baseline (prior to Cycle 1 docetaxel dose) and during Cycle 1 on Days 1, 2, 6, 7, 8, 9, 10, and 15 (pre-dose on dosing days; times equivalent to pre dose on other days).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. At least ā„ 18 years of age (male or female) at the time of signing the informed consent form.
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
ā. Patients with:
ā. Pathology confirmation of cancer
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) Myeloid Growth Factors:
ā. Prior chemotherapy or radiation treatment
ā. Bone marrow involvement by tumor
ā. Surgery and/or open wounds within 4 weeks of first administration of study drug
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, except adjuvant docetaxel given \> 1 year prior to first dose of study drug.
ā. 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 required use of strong CYP3A4 inhibitors (refer to Section 10.6.2)
What they're measuring
1
DSN
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
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 Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) treatment-emergent AEs (TEAEs).
ā. Received any concurrent anticancer therapies.
ā. Received a prior bone marrow or stem cell transplant.
ā. Had a co-existing active infection or received systemic anti-infective treatment within 72 hours before the first dose of study drug.