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Neuroendocrine CarcinomasPhase 2NCT02457273

Phase II Study to Evaluate the Efficacy and Safety of TLC388 for Differentiated Neuroendocrine Carcinomas Patients

A Phase 2 study testing TLC 388 in people with Neuroendocrine Carcinomas, run by National Health Research Institutes, Taiwan at 7 sites in Taiwan.

Completed

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

Official record
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Trial summary

Title of Study: An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated Neuroendocrine Carcinomas Investigational product: Lipotecan®* *Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Neuroendocrine Carcinomas
What is being tested?
TLC 388
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
7 sitesTaiwan
Study dates
4 Jul 2015to 1 Dec 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed poorly differentiated neuroendocrine carcinomas.
  • Patients who had first-line treatment failure (First line therapy must be etoposide plus platinum) due to treatment intolerance or radiographic progressive disease (as per RECIST v1.1).
  • At least one measurable lesion in a non-irradiated area.
  • Aged > 20 years old.
  • ECOG Performance Status ≤ 2.
  • Life expectancy greater than 12 weeks.
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  • Adequate bone marrow function :
  • absolutely neutrophil count ≥ 1500 /mm3 or WBC ≥ 4000/mm3
  • Hemoglobin > 9 g/dl
  • platelet count ≥ 100,000 /mm3
  • Adequate liver function :
  • ALT \& AST ≤ 2.5 x ULN if without liver metastasis or ≤ 5 x ULN if with hepatic metastasis Alkaline phosphatase ≤ 2.5 x ULN if without liver and bone metastasis; or ≤ 5 x ULN if with hepatic metastasis or bone metastasis
  • Total Bilirubin < 2 x ULN
  • Adequate renal function: creatinine < 1.5 x ULN.
  • Subjects who are willing and able to comply with all of the study procedures, and able to sign the informed consent.

Who cannot join

  • Major surgery within two weeks prior to entering the study.
  • Patients with CNS metastasis, including clinical suspicion.
  • Patients who are under active or uncontrolled infections.
  • Patients with concomitant illness that might be aggravated by chemotherapy.
  • Patients who are pregnant or with breast feeding.
  • Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
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  • Fertile men and women unless using a reliable and appropriate contraceptive method
  • A history of or the presence of one or more cardiac diseases, such as congestive heart failure (New York Heart Association Class III or IV), myocardial infarction or unstable angina and related surgeries, within 3 months prior to the initiation of the treatment dose.
  • Patients with a known history of human immunodeficiency virus infection.
  • The presence of active or uncontrolled systemic infection (bacterial, viral, other) except for chronic hepatitis B and hepatitis C.
  • Use of any investigational agent within 4 weeks of baseline.
  • Uncontrolled and unstable concurrent medical or psychiatric illness that will jeopardize the safety of the subject, interfere with the objectives of the protocol, or affect the subject compliance with study requirements, as determined by the investigator.
  • Known hypersensitivity or adverse drug reactions to Lipotecan® or its components.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Taiwan7 sites

  • Chung Gung Memorial Hospital(Kaohsiung City)

    Kaohsiung City

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Chang Gung Memorial Hospital (Lin-Kou),

    Linkou District

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng-Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects With Poorly Differentiated Neuroendocrine Carcinomas

Title of Study:

An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated Neuroendocrine Carcinomas

Investigational product:

Lipotecan®*

*Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I inhibitor)

Phase of development:

Phase II

Number of subjects:

Plan to enroll 44 subjects

Objectives:

Primary objectives:

To determine the objective response rate

Secondary objectives:

To evaluate Disease control rate, Progression free survival, Overall survival, Safety profile and Biomarkers

Read the detailed description

This is a phase II, open-label, single-arm, two-stage, multicenter study to evaluate the efficacy and safety of Lipotecan® monotherapy in subjects with poorly differentiated neuroendocrine carcinomas. Only those subjects who have failed to first line chemotherapy (Etoposide plus platinum) due to treatment intolerance or radiographic progressive disease (PD), as per RECIST v1.1, are eligible to participate in the study. The scheduled assessments should be performed as identified on a calendar schedule, and should not be affected by delays in therapy, drug holidays or any other events that might be lead to imbalance in a treatment arm in the timing of disease assessment. Efficacy results are based on radiographic assessments reviewed by the investigator.

Eligible subjects will receive 40 mg/m2 of Lipotecan®, given as a 30 (+3) minute intravenous infusion, on Days 1, 8 and 15 of a 28-day cycle until PD, unacceptable toxicity or consent withdrawal occurs.

Being tested
TLC 388
Keywords
PDNC(Poorly Differentiated Neuroendocrine Carcinomas), TLC-388 (Lipotecan®)
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

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

  • TLC 388Drug

    Also called Lipotecan®,

    40 mg/m2 of TLC 388, given as a 30 (+3) minute intravenous infusion, on Days 1, 8 and 15 of a 28-day cycle until PD, unacceptable toxicity or consent withdrawal occurs.

Study groups in NCT02457273
Study groupRoleWhat they receive
Assigned InterventionsExperimentalTLC 388
Receives: Drug: TLC 388

What is being measured

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

  1. the objective response rate

    Analysis for the objective response rate will be conducted on both the per protocol(PP) and evaluable data sets.

    Measured: 5 years

Secondary outcomes (4)

  1. Disease control rate

    The Disease control rate (DCR) is the percentage of subjects who have a best-response rating of CR or PR or SD (DCR= CR+PR+SD) (according to RECIST v1.1) when assessed after every 8 weeks of study drug (up to 6 cycles) and maintained for at least 28 days.

    Measured: 5 years

  2. Progression free survival

    Progression-free survival will be calculated as the duration between the first date of randomization and the date of disease recurrence or progression according to RECIST v1.1 (failed), taking the status of tumor at the treatment has been completed as the reference, or death (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).

    Measured: 5 years

  3. Overall survival

    Overall survival will be calculated from the date of randomization to either the date of death from all causes, or to the date of withdrawal (last contact date, censored), or to the scheduled data analysis date (censored).

    Measured: 5 years

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Physical examinations, lab abnormality and other toxicities graded by the NCI Common Toxicity Criteria will be examined to evaluate safety profiles of the study treatments. Particular attention will be paid to Grade 3 or 4 toxicities.

    Measured: 5 years

Timeline

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

  1. First posted29 May 2015 (estimated)
  2. Study start4 Jul 2015
  3. Primary completion18 Apr 2018
  4. Study completion1 Dec 2018

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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02457273
Sponsor's protocol ID
T1Z14
Status last verified
Dec 2018
First submitted
4 May 2015
Last updated
3 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen MH, Chou WC, Hsiao CF, Jiang SS, Tsai HJ, Liu YC, Hsu C, Shan YS, Hung YP, Hsich CH, Chiu CH, Liu TC, Cho SF, Liu TW, Chao Y. An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy of TLC388 and Genomic Analysis for Poorly Differentiated Neuroendocrine Carcinomas. Oncologist. 2020 May;25(5):e782-e788. doi: 10.1634/theoncologist.2019-0490. Epub 2019 Dec 18.

    PubMed 31852810

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TLC 388 in people with Neuroendocrine Carcinomas, run by National Health Research Institutes, Taiwan at 7 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 13 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

the objective response rate (time frame: 5 years). 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 NCT02457273, which also lists 1 linked publication.

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 3 Apr 2019.

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