CancerPhase 1/2NCT02925000
Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy
A Phase 1/2 study testing TLC178 in people with Cancer, run by Taiwan Liposome Company at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- TLC178
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Jun 2017to 6 Oct 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Karmanos Cancer Center
Detroit, Michigan, 48201
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- TLC178
- Keywords
- Advanced Malignancy, lymphoma, TLC178
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC178Drug
Also called Liposomal Vinorelbine
TLC178
| Study group | Role | What they receive |
|---|---|---|
| TLC178 | Experimental | Liposomal Vinorelbine Receives: Drug: TLC178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (17)
Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of vinorelbine[
Area under the plasma concentration time curve from zero (predose) extrapolated to infinity
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine
Area under the plasma concentration time curve from zero (predose) extrapolated to infinity
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration ofvinorelbine
Area under the plasma concentration time curve from zero (predose) to the time of the lastquantifiable concentration
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine
Area under the plasma concentration time curve from zero (predose) to the time of the lastquantifiable concentration
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of Cmax calculated by plasma concentration of vinorelbine
Maximum plasma concentration observed
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of vinorelbine
Time of Cmax
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of major metabolite,4-O-deacetylvinorelbine
Time of Cmax
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of vinorelbine
Apparent terminal half life
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of 4-O-deacetylvinorelbine
Apparent terminal half life
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of vinorelbine
Mean residence time extrapolated to infinity
Measured: from day 1 to day 29
Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of 4-O-deacetylvinorelbine
Mean residence time extrapolated to infinity
Measured: from day 1 to day 29
Dose exposure relationship in patients with advanced malignancies treated with single and multipledoses of LipoVNB
single and multiple dose effect
Measured: up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
treatment related AE
Measured: up to 6 months
Incidence of Treatment-Emergent Adverse Events
TEAE percentage
Measured: up to 6 months
LipoVNB antitumor activity assessed by response rate
antitumor response rate
Measured: up to 6 months
LipoVNB antitumor activity assessed by duration of response
antitumor efficacy
Measured: up to 6 months
Progression free survival (PFS) of patients with advanced malignancies treated with LipoVNB
PFS
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start19 Jun 2017
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Liposome Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Brown, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925000
- Sponsor's protocol ID
- TLC178A1001
- Status last verified
- Jul 2021
- First submitted
- 23 Aug 2016
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02925000
- Acronym / sponsor ID
- TLC178A1001
- Conditions
- Cancer
- Keywords
- Advanced Malignancy, lymphoma, TLC178
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taiwan Liposome CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TLC178 | Experimental | Drug: TLC178Liposomal Vinorelbine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLC178Also: Liposomal VinorelbineTLC178 | Drug | TLC178 |
Primary outcome
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.
17 secondary outcomes
Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of vinorelbine[
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of AUC (0-inf) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration ofvinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of AUC(0 - last) calculated by plasma concentration of majormetabolite, 4-O-deacetylvinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of Cmax calculated by plasma concentration of vinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of vinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of tmax calculated by plasma concentration of major metabolite,4-O-deacetylvinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of vinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of t1/2 calculated by plasma concentration of 4-O-deacetylvinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of vinorelbine
Time frame: from day 1 to day 29
Pharmacokinetics (PK) parameters of MRT(0-inf) calculated by plasma concentration of 4-O-deacetylvinorelbine
Time frame: from day 1 to day 29
Dose exposure relationship in patients with advanced malignancies treated with single and multipledoses of LipoVNB
Time frame: up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: up to 6 months
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 6 months
LipoVNB antitumor activity assessed by response rate
Time frame: up to 6 months
LipoVNB antitumor activity assessed by duration of response
Time frame: up to 6 months
Progression free survival (PFS) of patients with advanced malignancies treated with LipoVNB
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Brown study director
Taiwan Liposome Company
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TLC178 in people with Cancer, run by Taiwan Liposome Company at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) determination (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.