Spots Global Cancer Trial Database for Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
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Trial Identification
Brief Title: Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 2
Official Title: A Phase 2, Multicenter, Randomized Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy (Protective-1)
Study ID: NCT04345900
Conditions
Study Description
Brief 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).
Detailed Description: 55 patients with advanced and metastatic NSCLC have been randomized with the arm designation and planned intervention as follows: Arm 1: Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) Arm 2: Docetaxel (75 mg/m2) + plinabulin (20 mg/m\^2) Arm 3: Docetaxel (75 mg/m2) + plinabulin (10 mg/m\^2) Arm 4: Docetaxel (75 mg/m2) + plinabulin (5 mg/m\^2)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emad Ibrahim, MD, Inc., Redlands, California, United States
Mid Florida Hematology & Oncology Center, Orange City, Florida, United States
Cancer Center of Middle Georgia, Dublin, Georgia, United States
Hematology/Oncology of the North Shore, Skokie, Illinois, United States
Harbin Medical University Cancer Hospital, Harbin, Harbin, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Medical University 'REAVIZ', Samara, , Russian Federation
SBI of Healthcare "Oncology Dispensary #2" Ministry of Healthcare of Krasnodar Region, Sochi, , Russian Federation
Volgograd Regional Clinical Oncology Dispensary, Volgograd, , Russian Federation
Municipal Institution Dnipropetrovsk City Multi-functional Hospital, Dnepropetrovsk, , Ukraine
Prykarpatian Clinical Oncological Center, Ivano-Frankivs'k, , Ukraine
Kherson regional oncological dispensary Communal Institution of Kherson Regional council, Kherson, , Ukraine
Regional Municipal Institution "Kryvyy Rig Oncology Dispensary", Krivói Rog, , Ukraine
Kirovograd Regional Oncological Center, Kropyvnytskyi, , Ukraine
Kyiv City Clinical Oncology Center, Kyiv, , Ukraine
Lviv State Oncological Regional Treatment and Preventive Center, Lviv, , Ukraine
Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Sumy, , Ukraine
Zakarpattia Regional Clinical Oncology Center, Úzhgorod, , Ukraine
Contact Details
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