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

NCT02925000 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TLC178A1001
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cancer

Keywords

Advanced Malignancy; lymphoma; TLC178

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) determination

  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.

  4 weeks

Secondary Outcomes (17)

• Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of vinorelbine[

  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 AUC(0 - last) calculated by plasma concentration ofvinorelbine

  from day 1 to day 29

• 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 Cmax calculated by plasma concentration of vinorelbine

  from day 1 to day 29

Study Arms (1)

TLC178

EXPERIMENTAL

Liposomal Vinorelbine

Drug: TLC178

Interventions

TLC178 DRUG

TLC178

Also known as: Liposomal Vinorelbine

TLC178

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taiwan Liposome Company: lead

Study Sites (3)

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Carl Brown

  Taiwan Liposome Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: October 5, 2016
• Study Start: June 19, 2017
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); TW (1)