Spots Global Cancer Trial Database for Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Plinabulin vs. Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy Phase 3
Official Title: A Phase 3, Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy (Protective 1)
Study ID: NCT03102606
Conditions
Study Description
Brief 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\*
Detailed Description: Arm 1: Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin Arm 2: Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford University School of Medicine - Cancer Institute, Stanford, California, United States
Hematology/Oncology of the North Shore, Skokie, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Heilongjiang Cancer Hospital, Harbin, Heilongjiang, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Linyi Cancer Hospital, Linyi, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
Henan Cancer Hospital, Zhengzhou, , China
State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Interregional Oncology Dispensary", Pyatigorsk, , 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
Dnipropetrovsk City Multifunctional Hospital, Dnepropetrovsk, , Ukraine
Prykarpatskiy Regional Oncological Center, Ivano-Frankivsk, , Ukraine
Communal Institution of Kherson Regional Council "Kherson regional oncological dispensary", Kherson, , Ukraine
Kryvyi Rih Oncology Dispensary, Kryvyi Rih, , Ukraine
Lviv State Oncological Regional Treatment and Preventive Center, Lviv, , Ukraine
Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Sumy, , Ukraine
Contact Details
Name: Douglas W. Blayney, MD
Affiliation: Stanford University School of Medicine - Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
