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CarcinomaPhase 1NCT02703298

Safety and Pharmacokinetic Study of TRX-818 in Asian Solid Tumor Patients

A Phase 1 study testing TRX-818 capsules in people with Carcinoma and Advanced Cancer, run by TaiRx, Inc. at 1 site 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

TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Carcinoma, Advanced Cancer
What is being tested?
TRX-818 capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteTaiwan
Study dates
25 Mar 2016to 3 May 2018
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Tumor eligibility:
  • Histologically or cytologically confirmed advanced, non resectable, and/or metastatic solid tumor refractory to standard of care therapy, or for whom no standard of care therapy is available, or who were not amenable to established forms of treatment.
  • Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.
  • Female or male, 20 years of age or older.
  • ECOG performance status 0 to 2. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1 (except alopecia).
  • Adequate organ function as defined by the following criteria: Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy; Total serum bilirubin ≤1.5 x ULN (except for patients with documented Gilbert's syndrome) ; Absolute neutrophil count (ANC) >= 1500/µL; Platelets >= 90,000/µL ; Hemoglobin >= 9.0 g/dL; Serum creatinine ≤2.0 x ULN
  • Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Patients with leukemia, lymphomas, multiple myeloma, or other type of hematologic cancers.
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
  • Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • Current treatment on another clinical trial.
  • Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
  • Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6 month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
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  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Human immunodeficiency virus (HIV)-positive and is receiving anti-retroviral therapy.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
  • History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.
  • Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University Hospital

    Tainan, Tainan, 704

Other trials in Taiwan

About this study

Official title: A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Solid Tumors in Asians

TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in Asians and determine the recommended dose and regimen(s) to initiate Phase 2.

Being tested
TRX-818 capsules
Keywords
Advanced Solid Malignancy, Safety and Tolerability, Tumor Response, Oncology
Medical subject headings
Carcinoma, Neoplasms

What participants receive

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

  • TRX-818 capsulesDrug

Study groups in NCT02703298
Study groupRoleWhat they receive
TRX-818ExperimentalNot described
Receives: Drug: TRX-818 capsules

What is being measured

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

  1. Dose limiting toxicity (DLT) of TRX-818 in Asians

    Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.

    Measured: up to 28 days

  2. Maximum tolerated dose (MTD) of TRX-818 in Asians

    The MTD will be defined as the dose level at which at most one of six patients experiences a DLT after 28 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT.

    Measured: up to 28 days

Secondary outcomes (6)

  1. Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)

    Measured: up to 112 days

  2. Composite measure of pharmacokinetics (PK) parameters of TRX-818: AUC(0-last)

    AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration

    Measured: Day 1, 8, 15 for Cycle 1 only(each cycle is 28 days)

  3. Composite measure of pharmacokinetics (PK) parameters of TRX-818:Cmax

    Cmax: maximum plasma concentration

    Measured: Day 1, 8, 15 for Cycle 1 only(each cycle is 28 days)

  4. Composite measure of pharmacokinetics (PK) parameters of TRX-818: Tmax

    Tmax: time to maximum plasma concentration

    Measured: Day 1, 8, 15 for Cycle 1 only(each cycle is 28 days)

  5. Composite measure of pharmacokinetics (PK) parameters of TRX-818: T(1/2)

    T(1/2): terminal elimination half-life

    Measured: Day 1, 8, 15 for Cycle 1 only(each cycle is 28 days)

  6. Time to tumor progression (TTP)

    Measured: up to 112 days

Timeline

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

  1. First posted9 Mar 2016 (estimated)
  2. Study start25 Mar 2016
  3. Primary completion23 Jan 2018
  4. Study completion3 May 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02703298
Sponsor's protocol ID
CVM-002
Status last verified
Mar 2019
First submitted
22 Feb 2016
Last updated
28 Mar 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TRX-818 capsules in people with Carcinoma and Advanced Cancer, run by TaiRx, Inc. at 1 site 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 8 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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 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?

Dose limiting toxicity (DLT) of TRX-818 in Asians (time frame: up to 28 days). The study lists 2 primary outcomes in all. 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 NCT02703298.

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 28 Mar 2019.

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