NCT02925000

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	TLC178	TLC178

Timeline

• Start date: 2017-06-19
• Primary completion: 2020-10-06
• Completion: 2020-10-06
• First posted: 2016-10-05
• Last updated: 2021-07-23

Locations

3 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study