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

Taiwan Liposome Company (TLC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cancer

Treatments

Drug: TLC178

Study type

Interventional

Funder types

Industry

Identifiers

NCT02925000

TLC178A1001

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Male or female, ≥18 years of age (≥20 years of age in Taiwan)
Patients with histologically/cytologically confirmed solid tumor, or lymphoma including PTCL or CTCL.
Malignancies for which there is no standard therapy, or previously treated locally advanced, refractory/relapsed or metastatic disease for which local curative surgery, curable radiotherapy, or satisfactory systemic anticancer therapy is no longer available
Having at least one measurable tumor
ECOG Performance Status of ≤2
Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria

Patient with untreated or inadequate controlled brain metastases.
Prior systemic standard or investigational anticancer therapy, including target therapy, chemotherapy, immunotherapy within 28 days prior to the first dose of study drug. The above mentioned conditions which the Investigator considers there is no more drug effect, such as ≥5 half-lives are permitted
Prior radiotherapy within 4 weeks before screening
Prior autologous stem cell transplantation within 3 months of screening and allogeneic stem cell transplantation within 6 months of screening
More than 5 lines of previous cytotoxic therapies. For patients of CTCL who failed romidepsin, more than 4 lines of previous therapies
Major surgery within 4 weeks prior to first administration of study drug
History of myocardial infarction, unstable angina or severe congestive heart failure (New York Heart Classification Class IV) or major stroke within 3 months prior to screening period
Medical history of uncontrolled but clinically significant abnormal cardiac conduction abnormalities at electrocardiogram (ECG) at screening, any history or evidence of long QT syndrome or QTcF interval >450 msec for males and >470 msec for females (according to Fridericia's correction) at screening
Known HIV infection; active hepatitis B or C without concurrent treatment
Coexistence of any active and uncontrolled infection
Poor vital organ function defined
Uncontrolled and unstable concurrent medical condition including psychiatric disorders and alcohol/substance dependence/abuse that will jeopardize the safety of the patient, interfere with the objectives of the study, or affect the patient compliance with study requirements, as determined by the Investigator
Known allergy or hypersensitivity to the study drug or its components
Use of strong inhibitors or inducers of cytochrome P450 enzymes CYP3A4
Pregnant or breast feeding women.