AzTrials
AzTrials

Advanced/Metastasis Renal Cell CarcinomaPhase 2NCT01831973

A Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Advanced/Metastatic RCC Patients

A Phase 2 study testing Lipotecan in people with Advanced/Metastasis Renal Cell Carcinoma, run by Taiwan Liposome Company at 5 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

INVESTIGATIONAL PRODUCT: TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl. PHASE OF DEVELOPMENT: Phase II No. OF PATIENTS: Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients) STUDY OBJECTIVES: Primary To evaluate non-progression disease (non-PD) rate at the end of cycle 6… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastasis Renal Cell Carcinoma
What is being tested?
Lipotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
5 sitesTaiwan
Study dates
30 Nov 2012to 21 Feb 2017
Phase
Phase 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

  • Adult patients defined by age ≥ 18 years
  • Histologically confirmed Renal cell carcinoma (RCC)
  • Locally advanced or metastatic RCC. Locally advanced RCC: defined as a stage T3/T4 disease, not amenable to curative surgery or radiation therapy, with involvement of renal vein/vena cava/peripelvic and perirenal fat/adrenal gland, or invasion beyond Gerota's fascia. Metastatic RCC: equivalent to Stage IV RCC, according to American Joint Committee on Cancer (AJCC) staging
  • Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤ 2. But for the patient with failure of ≥ 2 prior target therapies, ECOG should be ≤ 1.
  • Documented RCC disease with measurable or non-measurable lesion on imaging by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) criteria
  • Documented treatment failure of at least 1 prior target therapy (sorafenib, sunitinib pazopanib or other VEGF TKI, bevacizumab, temsirolimus, everolimus or other mTOR inhibitor) for advanced or metastatic RCC. If treatment-naïve, patients with poor prognosis features according to Memorial Sloan-Kettering Cancer Centre (MSKCC) risk criteria are acceptable
Show all 15Show fewer
  • Any acute or chronic adverse effects of prior therapy have resolved to <Grade 2 as determined by CTCAE v4.0 criteria
  • Laboratory values at screening:
  • Absolute neutrophil count ≥ 1,500 /mm3;
  • Platelets ≥ 100,000 /mm3;
  • Hemoglobin ≥ 9.0 g/dL;
  • Total bilirubin ≤ 1.5 times the upper limit of normal;
  • AST (SGOT) ≤ 2.5 times the upper limit of normal;
  • ALT (SGPT) ≤ 2.5 times the upper limit of normal;
  • Serum creatinine ≤ 2 times the upper limit of normal;

Who cannot join

  • Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrolment. Male and female patients of childbearing potential must agree to use appropriate birth control (barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records)
  • Receipt of any chemotherapy for RCC
  • Had cardiac angioplasty or stenting event, myocardial infarction or unstable angina within 3 months of study entry
  • Persistent QTc >450 ms for males, or >470 ms for females, according to Fridericia's correction
  • Patients with Grade 3 or greater hyponatremia at screening
  • History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification
Show all 16Show fewer
  • History of another malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, and not disease free ≥5 years
  • History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam
  • History of human immunodeficiency virus infection
  • Presence of active, uncontrolled infection
  • Radiotherapy received within 4 weeks prior to baseline
  • Use of any investigational agents within 4 weeks of baseline
  • Major surgery within 4 weeks prior to baseline
  • Receipt of radiotherapy to >25 % of bone marrow
  • Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents which are potent inhibitors or inducers of cytochrome P450 enzymes (Appendix D1), unless approved by the Sponsor
  • Uncontrolled intercurrent illness that would jeopardize patient safety, or interfere with the objectives of the protocol, or limit patient compliance with study requirements, as determined by the Investigator

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Taiwan5 sites

  • Chang Gung Memorial Hospital. Kaohsiung Branch

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Memorial Hospital: LinKou Branch

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: An Open-Label, Single-Arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Patients With Advanced/Metastatic Renal Cell Carcinoma

INVESTIGATIONAL PRODUCT:

TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl.

Read more

PHASE OF DEVELOPMENT:

Phase II

No. OF PATIENTS:

Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients)

STUDY OBJECTIVES:

Primary

  • To evaluate non-progression disease (non-PD) rate at the end of cycle 6

Secondary

  • To evaluate progression free survival (PFS)
  • To evaluate overall survival (OS)
  • To evaluate the duration of non-PD
  • To evaluate objective response rate (ORR; where ORR= CR+PR) and duration
  • To evaluate the safety profile of TLC388
  • To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6

STUDY DESIGN:

This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).

Read the detailed description

A Phase II, open-label, single-arm, multi-center study to evaluate TLC388 monotherapy in patients with locally advanced and/or metastatic RCC. The study consisted of a Screening/Baseline Period, a Treatment Period and a post-treatment Follow-Up Period for PFS and OS.

Patients were to be recruited at two stages. Stage I recruited 15 evaluable patients, who had completed at least 2 cycles of treatment with one tumor assessment. If ≤ 5 patients did not develop PD at the end of cycle 6 per RECIST, no patients were to be recruited for Stage II and the study was to be closed. If > 5 patients did not develop PD at the end of cycle 6, a total of 40 evaluable patients (additional 25 evaluable patients for Stage II) were to be recruited thereafter.

Being tested
Lipotecan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LipotecanDrug

    Also called TLC388

Study groups in NCT01831973
Study groupRoleWhat they receive
Lipotecan, injection for chemotherapyExperimentalPatients receive TLC388 (50 mg/m2) given as a 30-minute IV infusion, on Days 1, 8, and 15 of a 28-day cycle.
Receives: Drug: Lipotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Non-progression disease (non-PD) rate at the end of cycle 6

    Non-progression disease rate after cycle 6

    Measured: 6 months

Secondary outcomes (6)

  1. Progression free survival (PFS)

    Progression free survival

    Measured: 3 years

  2. Overall survival (OS)

    Overall sruvival

    Measured: 3 years

  3. Duration of non-PD

    Non-progression disease rate (overall)

    Measured: 3 years

  4. Objective response rate (ORR; where ORR= CR+PR) and duration

    Objective response rate and duration

    Measured: 3 years

  5. Safety profile of TLC388

    Serious/ Adverse Events

    Measured: 3 years

  6. Change in health-related quality of life (HRQOL) at the end of cycle 6

    Quality of life after cycle 6

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study start30 Nov 2012
  3. Primary completion19 Mar 2015
  4. Study completion21 Feb 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831973
Sponsor's protocol ID
TLC388.3
Status last verified
Jun 2018
First submitted
27 Mar 2013
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lipotecan in people with Advanced/Metastasis Renal Cell Carcinoma, run by Taiwan Liposome Company at 5 sites in Taiwan.

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 15 inclusion and 16 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in 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 phase mean?

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?

Non-progression disease (non-PD) rate at the end of cycle 6 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831973.

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 26 Jun 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in