Spots Global Cancer Trial Database for Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy
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Trial Identification
Brief Title: Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy
Official Title: A Phase I/IIa, Open Label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy
Study ID: NCT02925000
Conditions
Interventions
Study Description
Brief Summary: This is a phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy.
Detailed Description: Protocol No: TLC178A1001 Name of Finished Product: LipoVNB (Liposomal Vinorelbine Tartrate) Title of Study: Phase I/IIa, Open label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients with Advanced Malignancy. Study duration: Every patient will have a treatment period of 4-week cycles until completion of 6 cycles, progression of disease or intolerance, withdrawal of consent or Investigator's judgment, whichever occurs first.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Karmanos Cancer Center, Detroit, Michigan, United States
Montefiore Medical Center, Bronx, New York, United States
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Carl Brown
Affiliation: Taiwan Liposome Company
Role: STUDY_DIRECTOR
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