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
Overview
- Phase
- Phase 1
- Intervention
- TLC178
- Conditions
- Cancer
- Sponsor
- Taiwan Liposome Company
- Enrollment
- 46
- Locations
- 3
- Primary Endpoint
- Maximum tolerated dose (MTD) determination
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TLC178
Liposomal Vinorelbine
Intervention: TLC178
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD) determination
Time Frame: 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 Outcomes
- Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of vinorelbine[(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- Progression free survival (PFS) of patients with advanced malignancies treated with LipoVNB(up to 6 months)
- Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration ofvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of 4-O-deacetylvinorelbine(from day 1 to day 29)
- Dose exposure relationship in patients with advanced malignancies treated with single and multipledoses of LipoVNB(up to 6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03(up to 6 months)
- Incidence of Treatment-Emergent Adverse Events(up to 6 months)
- LipoVNB antitumor activity assessed by response rate(up to 6 months)
- Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of Cmax calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of major metabolite,4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of 4-O-deacetylvinorelbine(from day 1 to day 29)
- Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of vinorelbine(from day 1 to day 29)
- LipoVNB antitumor activity assessed by duration of response(up to 6 months)