Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female, ≥18 years of age (≥20 years of age in Taiwan)
  2. Patients with histologically/cytologically confirmed solid tumor, or lymphoma. For the expansion cohort, only patients with peripheral/cutaneous T cell lymphoma, Hodgkin's lymphoma, and other non-Hodgkin's lymphoma would be considered eligible
  3. 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
  4. Assessable disease status defined by Cheson (for lymphoma) or modified severity weighted assessment tool (mSWAT) (for mycosis fungoides [MF] and Sezary syndrome [SS]) criteria, or having measurable tumors defined by Response Evaluation Criteria in Solid Tumors guidelines (RECIST 1.1) (for solid tumor)
  5. Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2
  6. Anticipated life expectancy of more than 3 months per Investigator's judgement
  7. Women of childbearing potential must have a negative urine pregnancy test at the screening visit
  8. Male patients with female partners of childbearing potential, and female patients of childbearing potential must agree to use effective birth control. Effective birth control and cessation of lactation must be complied at least 2 weeks prior to first study drug administration, during the trial participation, and for 3 months after the last dose of study drug
  9. Willing and able to comply with the study procedure and sign a written informed consent

Exclusion Criteria

  1. Patient with untreated or inadequate controlled brain metastases. Brain metastases or lymphoma with CNS involvement previously treated by radiotherapy or other modality and stable for at least 3 months prior to screening without requirement of corticosteroids or anticonvulsants are permitted
  2. 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
  3. More than 5 lines of previous cytotoxic therapies. For patients of CTCL who failed romidepsin, more than 4 lines of previous therapies
  4. Extensive prior radiotherapy on more than 30% of bone marrow reserves or prior bone marrow/stem cell transplantation within 2 years before screening. Limited field radiation for ≤2 weeks prior to screening period is permitted
  5. Any toxicity due to prior therapy that has not been resolved to less than Grade 2 severity by Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03 or higher) criteria
  6. Medical history of uncontrolled but clinically significant abnormal cardiac conduction abnormalities at electrocardiogram (ECG), 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
  7. Poor vital organ function defined as:
  8. Absolute neutrophil count (ANC) <1,500/mm3, pre-transfusion platelets <100,000/mm3, or pre-transfusion hemoglobin <9.0 mg/dL (the patient is required to have at least 2 weeks free from blood transfusion, G-CSF and erythropoietin use prior to the hematology test)
  9. International Normalized Ratio (INR) for coagulation above upper normal range
  10. Total bilirubin >1.5 times upper limit of normal (ULN)
  11. Aspartate amino transferase (AST) or Alanine amino transferase (ALT) >3 times ULN in patient without liver metastasis or liver cirrhosis
  12. Child Pugh B or C stage liver disease
  13. Creatinine clearance (by Cockcroft Gault formula) <40 mL/min
  14. Use of potent inhibitors or inducers of cytochrome P450 enzymes CYP3A4 within 14 days prior to first study drug administration.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TLC178
Liposomal Vinorelbine
  • Drug: TLC178
    TLC178
    Other names:
    • Liposomal Vinorelbine

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Sanjay Goel

More Details

Status
Recruiting
Sponsor
Taiwan Liposome Company

Study Contact

Renee Chih
886 2 26557377
renee@tlcbio.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.