Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy
- Registration Number
- NCT02925000
- Lead Sponsor
- Taiwan Liposome Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TLC178 TLC178 Liposomal Vinorelbine
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) determination 4 weeks To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) ofintravenous LipoVNB given every 4 weeks (Q4W) in patients with advanced malignancies.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of vinorelbine[ from day 1 to day 29 Area under the plasma concentration time curve from zero (predose) extrapolated to infinity
Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of vinorelbine from day 1 to day 29 Time of Cmax
Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of vinorelbine from day 1 to day 29 Apparent terminal half life
Progression free survival (PFS) of patients with advanced malignancies treated with LipoVNB up to 6 months PFS
Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration ofvinorelbine from day 1 to day 29 Area under the plasma concentration time curve from zero (predose) to the time of the lastquantifiable concentration
Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of 4-O-deacetylvinorelbine from day 1 to day 29 Mean residence time extrapolated to infinity
Dose exposure relationship in patients with advanced malignancies treated with single and multipledoses of LipoVNB up to 6 months single and multiple dose effect
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 up to 6 months treatment related AE
Incidence of Treatment-Emergent Adverse Events up to 6 months TEAE percentage
LipoVNB antitumor activity assessed by response rate up to 6 months antitumor response rate
Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine from day 1 to day 29 Area under the plasma concentration time curve from zero (predose) to the time of the lastquantifiable concentration
LipoVNB antitumor activity assessed by duration of response up to 6 months antitumor efficacy
Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine from day 1 to day 29 Area under the plasma concentration time curve from zero (predose) extrapolated to infinity
Pharmacokinetics (PK) parameters of Cmax calculated by plasma concentration of vinorelbine from day 1 to day 29 Maximum plasma concentration observed
Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of major metabolite,4-O-deacetylvinorelbine from day 1 to day 29 Time of Cmax
Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of 4-O-deacetylvinorelbine from day 1 to day 29 Apparent terminal half life
Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of vinorelbine from day 1 to day 29 Mean residence time extrapolated to infinity
Trial Locations
- Locations (3)
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Montefiore Medical Center
🇺🇸Bronx, New York, United States