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Hepatocellular CarcinomaPhase 1NCT03738111

Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma

A Phase 1 study testing TG02 Citrate in people with Hepatocellular Carcinoma, run by Lee's Pharmaceutical Limited.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single-centre, open-label, dose escalation, Phase 1 study. The primary objective is to determine the highest dose of TG02 citrate that can safely be given to patients with advanced hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
TG02 Citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2018to Dec 2021
Phase
Phase 1
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

  • Adults ≥ 18 years of age at screening;
  • Life expectancy ≥ 3 months;
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1;
  • Subjects must have histologically confirmed locally advanced or metastatic hepatocellular carcinoma (HCC) and have tumor that is refractory to or progressive after sorafenib treatment. Or the subjects are intolerable to sorafenib.
  • Prior local therapy to tumor (e.g. surgery, radiofrequency ablation, percutaneous ethanol injection, chemo-embolization, radiotherapy) is allowed provided that there is a target lesion not subjected to local therapy and/or disease progression has been documented in the target lesion subjected to local therapy. The treatment must be completed at least 4 weeks and patient has recovered from all the acute toxicities of that treatment.
  • At least 28 days, or at least 5 half-lives (whichever is shorter), since last systemic therapy (i.e., chemotherapy, targeted therapy, immunotherapy) before the first dosing of TG02, and have recovered from any clinically significant toxicity associated with such treatment;
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  • HCC subjects must be of Child-Pugh class A (not amenable to or refractory to locoregional therapy). Subjects with HCC associated with hepatitis B virus must be receiving adequate antiviral therapy.
  • Must have at least 1 measurable lesion per RECIST 1.1 and evidence of disease progression since the last anti-tumor therapy.
  • Adequate hematologic, renal and hepatic function:
  • White Blood Cells ≥2000/uL Neutrophils ≥1500/uL Platelets ≥75,000/uL Hemoglobin ≥9.0g/dL (may have been transfused) Creatinine ≤2mg/dL Aspartate Aminotransferase (AST) <5 x upper limit of normal (ULN) alanine aminotransferase (ALT) <5 x upper limit of normal (ULN) Bilirubin ≤2 x ULN (except subjects with Gilbert's syndrome, who must have total bilirubin <3.0mg/dL) INR ≤1.5
  • Persistent clinically significant toxicities from prior chemotherapy must be ≤ grade 1.
  • Ability to take oral medicine.
  • Negative urine pregnancy test at the time of first dose for women of child bearing potential (WOCBP). For men and WOCBP, adequate contraception must be used throughout the study. For this study, acceptable methods of contraception include a reliable intrauterine device or a spermicide in combination with a barrier method. Hormonal forms of birth control (oral, implantable, or injectable) may only be used if combined with a barrier method.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.

Who cannot join

  • Past liver transplantation.
  • Uncontrollable hepatic encephalopathy or ascites.
  • Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, and myocardial infarction within 6 months prior to first dose.
  • Screening ECG with a prolonged QTc interval (males: >450ms; females: >470ms) as calculated by the Fridericia correction formula despite balancing of electrolytes and/or discontinuing any drugs known to prolong QTc interval.
  • Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, hypertension, coronary artery disease) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
  • Symptomatic CNS or brain metastases.
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  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Prior or second malignancy, except non-melanoma skin cancer, completed resected cervical or prostate cancer (with prostate-specific antigen (PSA) of less than or equal to 0.1ng/ml), or other cancer for which the subjects has received curative therapy at least 3 years prior to study entry.
  • Patient with pleural effusions requiring thoracentesis or ascites requiring paracentesis.
  • Acute hepatitis.
  • The subject is receiving an investigational drug, has an investigational device in place or has participated in an investigational drug or device study within 30 days prior to screening.
  • Pregnant or nursing.
  • History of drug abuse and taking drugs (such as marijuana, cocaine, opiates, benzodiazepines, amphetamines, barbiturates).
  • History of addicted to alcohol within 6 months before the study which defines as an average weekly intake of greater than 14 units (one unit=17.7ml ethanol, which is equivalent to 357ml beer with 5% alcohol content or 44ml spirits with 40% alcohol content or 147ml wine with 12% alcohol content).
  • Subjects who, in the opinion of the investigators, should not participate in the study.

About this study

Official title: A Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma

This is a single-centre, open-label, dose escalation, Phase 1 study. The primary objective is to determine the highest dose of TG02 citrate that can safely be given to patients with advanced hepatocellular carcinoma.

Being tested
TG02 Citrate
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • TG02 CitrateDrug

    TG02 citrate capsules

Study groups in NCT03738111
Study groupRoleWhat they receive
TG02 CitrateExperimentalTG02 citrate capsules given orally.
Receives: Drug: TG02 Citrate

What is being measured

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

  1. Maximum Tolerated Dose

    To assess the number of patients with dose-limiting toxicities (DLT) and the dose of TG02 citrate that can be safely given to patients with advanced hepatocellular carcinoma.

    Measured: 28 days

Secondary outcomes (4)

  1. Adverse Event

    All adverse events will be graded according to NCI-CTCAE, Version 4

    Measured: up to 12 months

  2. Objective Response Rate, with respect to RECIST version 1.1

    Proportion of patients, whose best overall response is either Complete Response or Partial Response, confirmed at least 4 weeks after initial documentation.

    Measured: Up to 12 months

  3. Progression Free Survival

    Measured: At progression, up to 12 months

  4. Overall Survival

    Measured: At death, up to 12 months

Timeline

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

  1. First posted13 Nov 2018
  2. Study startDec 2018 (estimated)
  3. Primary completionAug 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Sponsor's commercial decision

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738111
Sponsor's protocol ID
COF-HK-001
Status last verified
Sep 2019
First submitted
1 Nov 2018
Last updated
25 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TG02 Citrate in people with Hepatocellular Carcinoma, run by Lee's Pharmaceutical Limited.

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 14 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: withdrawn, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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 was withdrawn before enrolling participants, so there are no results.

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 (time frame: 28 days). 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 NCT03738111.

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 25 Sep 2019.

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