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Clinical Trials List

Protocol NumberTAI-002
NCT Number(ClinicalTrials.gov Identfier)NCT03349073

2018-01-17 - 2020-04-30

Phase I

Suspended4

ICD-10C80.1

Malignant (primary) neoplasm, unspecified

An Extension Study of T-1101 (Tosylate) Administered Orally to Patients With Advanced Refractory Solid Tumors

  • Trial Applicant

    Efficient Pharma Management Corp.

  • Sponsor

    Taivex Therapeutics Corporation

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Li-Tzong Chen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Audit

None

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Principal Investigator Li-Yuan Bai 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Suspended

Audit

None

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Suspended

Audit

None

Condition/Disease

Advanced Refractory Solid Tumors

Objectives

The primary purpose of this study is to enable patients, currently receiving single agent T-1101 (Tosylate) treatment in a Taivex Therapeutics Corporation sponsored clinical trial, to continue T-1101 (Tosylate) treatment after their respective study has met its primary endpoint and/or has reached the end as defined in the original protocol TAI-001. Patients will be able to continue T-1101 (Tosylate) treatment until the treating physician feels the patient is no longer benefiting from the treatment or T-1101 (Tosylate) becomes commercially available, as applicable in the country in which the patient lives.

Test Drug

T-1101 (Tosylate)

Active Ingredient

T-1101

Dosage Form

oral

Dosage

14.5/25.0/29.0/33.0

Endpoints

Primary Outcome Measures :
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 ]

Inclution Criteria

Inclusion Criteria
Patients presenting with all of the following will be included in the extension trial:
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
Patients presenting with any of the following will not be included in the extension trial:
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.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    0 participants

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