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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03349073
Recruitment Status : Enrolling by invitation
First Posted : November 21, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Taivex Therapeutics Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Refractory Solid Tumors Drug: T-1101 (Tosylate) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of T-1101 (Tosylate) Administered Orally to Patients With Advanced Refractory Solid Tumors
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: T-1101 (Tosylate) Drug: T-1101 (Tosylate)
T-1101 (Tosylate) powder in bottle




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349073


Locations
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Taiwan
National Cheng Kung University (NCKU) Hospital
Tainan, Taiwan, 704
Taipei Medical University Hospital
Taipei, Taiwan, 105
Sponsors and Collaborators
Taivex Therapeutics Corporation

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Responsible Party: Taivex Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT03349073     History of Changes
Other Study ID Numbers: TAI-002
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No