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

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: NCT03195764
Recruitment Status : Enrolling by invitation
First Posted : June 22, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Taivex Therapeutics Corporation

Brief 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. 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.

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: 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
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

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




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of T-1101 (Tosylate) in Participants with Advanced Cancers Refractory to Standard Therapy [ Time Frame: The first 21-day cycle ]

    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.



Secondary Outcome Measures :
  1. Pharmacokinetics: Peak maximum plasma concentration (Cmax) and minimum plasma concentration (Cmin) of T-1101 (Tosylate) and its metabolites [ Time Frame: 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 [ Time Frame: Selected time points during first 21-day cycle ]
    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.

  3. Pharmacokinetics: Time to maximum plasma concentration (Tmax) and terminal half-life (T½) of T-1101 (Tosylate) and its metabolites [ Time Frame: Selected time points during first 21-day cycle ]
    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.

  4. Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate) and its metabolites [ Time Frame: Selected time points during first 21-day cycle ]
  5. Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate) and its metabolites [ Time Frame: Selected time points during first 21-day cycle ]
  6. Clinical Tumor Response of T-1101 (Tosylate) in Participants with Advanced Cancers [ Time Frame: Up to 2 years ]
    Categorization of response based on RECIST 1.1.



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. 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.
  2. Able, in the investigator's opinion, to have a life expectancy of more than 3 months.
  3. Female or male, 20 years of age or older.
  4. ECOG performance status 0 or 1.
  5. Resolution of all acute toxic effects of prior therapy or surgical procedures to no more than grade 1 (except alopecia).
  6. 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
  7. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
  8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

  1. Major surgery (as defined by investigator) within 4 weeks of starting treatment.
  2. Extensive radiation therapy or systemic cytotoxic chemotherapy within 4 weeks before starting study treatment or target therapy within 2 weeks of starting study treatment.
  3. Current treatment on clinical trial or within 4 weeks of completion of clinical trial for another investigation drug.
  4. Documented or suspicious brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
  5. 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.
  6. Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, or atrial fibrillation of any grade.
  7. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  8. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  9. Known human immunodeficiency virus infection.
  10. 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.
  11. 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.
  12. Patients with active infection should be excluded.
  13. Positive test for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody).

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): NCT03195764


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 701
Taipei Medical University Hospital
Taipei, Taiwan, 110
National Taiwan University Hospital
Taipei, Taiwan, 115
Sponsors and Collaborators
Taivex Therapeutics Corporation

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Responsible Party: Taivex Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT03195764     History of Changes
Other Study ID Numbers: TAI-001
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
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