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Advanced Refractory Solid TumorsPhase 1NCT03195764

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

A Phase 1 study testing T-1101 (Tosylate) in people with Advanced Refractory Solid Tumors, run by Taivex Therapeutics Corporation at 4 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) 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
Advanced Refractory Solid Tumors
What is being tested?
T-1101 (Tosylate)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesTaiwan
Study dates
14 Sep 2017to 23 Oct 2019
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 confirmed advanced malignancies refractory to standard active treatment.
  • Solid tumors that 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.
  • Able, in the investigator's opinion, to have a life expectancy of more than 3 months.
  • Female or male, 20 years of age or older.
  • ECOG performance status 0 or 1.
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  • Resolution of all acute toxic effects of prior therapy or surgical procedures to no more than grade 1 (except alopecia).
  • Adequate organ function as defined by the following criteria:
  • Serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or ALT ≤ 5 x ULN if liver tumor is present.
  • Total serum bilirubin ≤1.5 x ULN
  • WBC ≥ 4000/µL with an absolute neutrophil count (ANC) ≥1500/µL
  • Platelets ≥ 100,000/µL
  • Hemoglobin ≥ 9.0 g/dL
  • CCr ≥ 50 mL/min
  • Signed and dated informed consent document indicating that the patient 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

  • Major surgery (as defined by investigator) within 4 weeks of starting treatment.
  • Extensive radiation therapy or systemic cytotoxic chemotherapy within 4 weeks before starting study treatment or target therapy within 2 weeks of starting study treatment.
  • Current treatment on clinical trial or within 4 weeks of completion of clinical trial for another investigation drug.
  • Documented or suspicious brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
  • Any of the following occurs within 6 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.
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, or atrial fibrillation of any grade.
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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).
  • Known human immunodeficiency virus infection.
  • Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to the use of highly effective contraception during the period of therapy. Highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, or a vasectomized partner. 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 condition or laboratory abnormality 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.
  • Patients with active infection should be excluded.
  • Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody).

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan, 701

  • Taipei Medical University Hospital

    Taipei, 110

  • National Taiwan University Hospital

    Taipei, 115

Other trials in Taiwan

About this study

Official title: A Phase I Safety and Tolerability Study of T-1101 (Tosylate) as a Oral Powder for Constitution (OPC) in Patients With Advanced Refractory Solid Tumors

T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human cancers. In this study, safety, tolerability and PK of T-1101 (Tosylate) will be evaluated and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.

Being tested
T-1101 (Tosylate)

What participants receive

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

  • T-1101 (Tosylate)Drug

    T-1101 (Tosylate) powder in bottle

Study groups in NCT03195764
Study groupRoleWhat they receive
T-1101 (Tosylate)ExperimentalNot described
Receives: Drug: T-1101 (Tosylate)

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy

    MTD is highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT).

    When following toxicity events occur within the first 21-day cycle, these toxicity will be defined as DLT.

    1. Hematological toxicities : prolonged grade 4 neutropenia for >7 days, grade 3 febrile neutropenia (an ANC < 1000/mm3 with a single temperature of > 38.3°C or a sustained temperature of > 38°C for more than 1 hour), grade 4 febrile neutropenia (febrile neutropenia with life-threatening consequences; urgent intervention indicated), grade 3 neutropenia with grade 3 infection and grade 3 thrombocytopenia with bleeding or grade 4 lasting 7 days.
    2. Non-hematological toxicities: grade 3 or 4 toxicities, Nausea and vomiting or diarrhea must persist at grade 3 or 4 despite maximal medical therapy.

    The above toxicities will be graded according to the NCI CTCAE v4.03.

    Measured: The first 21-day cycle

Secondary outcomes (6)

  1. Pharmacokinetics: Peak maximum plasma concentration (Cmax) and minimum plasma concentration (Cmin) of T-1101 (Tosylate) and its metabolites

    Measured: Selected time points during first 21-day cycle

  2. Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) to the time of the last measurable concentration and to infinity of T-1101 (Tosylate) and its metabolites

    Area under the plasma concentration versus time curve to the time of the last measurable concentration (AUC0-last) of T-1101 (Tosylate) and its metabolites will be estimated using non-compartmental analysis. If data permit, area under the plasma concentration versus time curve to infinity (AUC0-∞) will be also estimated.

    Measured: Selected time points during first 21-day cycle

  3. Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate) and its metabolites

    Time to maximum plasma concentration (Tmax) of T-1101 (Tosylate) and its metabolites will be estimated using non-compartmental analysis. If data permit, terminal elimination half-life (T½ ) will be also estimated.

    Measured: Selected time points during first 21-day cycle

  4. Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate) and its metabolites

    Measured: Selected time points during first 21-day cycle

  5. Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate) and its metabolites

    Measured: Selected time points during first 21-day cycle

  6. Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers

    Categorization of response based on RECIST 1.1.

    Measured: Up to 2 years

Timeline

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

  1. First posted22 Jun 2017
  2. Study start14 Sep 2017
  3. Primary completion1 Oct 2019
  4. Study completion23 Oct 2019

Why it stopped: The study was terminated before the primary endpoint (determination of MTD) was reached because the OPC form is to be replaced with the newly developed capsule form in all subsequent clinical trials.

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03195764
Sponsor's protocol ID
TAI-001
Status last verified
Nov 2022
First submitted
8 May 2017
Last updated
18 Nov 2022
Results posted
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 T-1101 (Tosylate) in people with Advanced Refractory Solid Tumors, run by Taivex Therapeutics Corporation at 4 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 16 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: stopped early, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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 stopped early (reason given: The study was terminated before the primary endpoint (determination of MTD) was reached because the OPC form is to be replaced with the newly developed capsule form in all subsequent clinical trials.). Results are not available in the source record.

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) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy (time frame: The first 21-day cycle). 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 NCT03195764.

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 18 Nov 2022.

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