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CompletedNCT03349073Updated Nov 18, 2022

An Extension Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

A Phase 1 interventional study of T-1101 (Tosylate) in Advanced Refractory Solid Tumors, sponsored by Taivex Therapeutics Corporation. Completed at 4 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Taivex Therapeutics Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
20 Years and older
Sex
All
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Study summary

T-1101 is a novel anti-cancer agent being developed by Taivex Therapeutics Corporation, and is being studied in a phase I dose escalation trial, protocol TAI-001. That trial's primary aim is to study the safety and tolerability of T-1101 (Tosylate) in subjects with advanced refractory solid tumors, and provides for a maximum of 2 cycles of treatment. At the end of 2 cycles of treatment, it is likely that some patients will be continuing to receive clinical benefit from T-1101 (Tosylate). The intention of this program is to enable these patients to continue to receive T-1101 (Tosylate) at the discretion of the principal investigators and Taivex Therapeutics Corporation.

02

Conditions studied

  • Advanced Refractory Solid Tumors

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03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with advanced malignancy who are receiving T-1101 (Tosylate) in a previous Taivex Therapeutics Corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment.
  2. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing.
  3. Women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of T-1101 (Tosylate) in this long term extension trial.
  4. Patients who have completed the End of Study assessments in their originating study. Every effort should be made to conduct the End of Study visit such that the patient does not have any interruption in T-1101 (Tosylate) dosing.
  5. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
  6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient.
  2. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  3. Progressive or untreated metastatic brain or meningeal tumors.
  4. Pregnancy or breastfeeding. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. 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.
  5. Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    T-1101 (Tosylate)

    Drug: T-1101 (Tosylate)

Interventions

  • DrugT-1101 (Tosylate)

    T-1101 (Tosylate) powder in bottle

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What researchers measure

Primary outcomes

  1. Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers Categorization of response based on RECIST 1.1.

    Time frame: Up to 2 years

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Study locations

4 sites
  • China Medical University Hospital
    Taichung City, Taiwan
  • National Cheng Kung University (NCKU) Hospital
    Tainan, 704, Taiwan
  • Taipei Medical University Hospital
    Taipei, 105, Taiwan
  • National Taiwan University Hospital
    Taipei, Taiwan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03349073
Lead sponsor
Taivex Therapeutics Corporation
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Sep 14, 2017
Primary completion
Jun 24, 2019
Completion
Jun 24, 2019
Last update
Nov 18, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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