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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

Tracking Information
First Submitted Date  ICMJE May 8, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date September 19, 2017
Actual Study Start Date  ICMJE September 14, 2017
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03195764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • 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 ]
  • 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.
  • 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.
  • Pharmacokinetics: Oral plasma clearance (CL/F) of T-1101 (Tosylate) and its metabolites [ Time Frame: Selected time points during first 21-day cycle ]
  • Pharmacokinetics: Apparent volume of distribution (Vd/F) of T-1101 (Tosylate) and its metabolites [ Time Frame: Selected time points during first 21-day cycle ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Refractory Solid Tumors
Intervention  ICMJE Drug: T-1101 (Tosylate)
T-1101 (Tosylate) powder in bottle
Study Arms  ICMJE Experimental: T-1101 (Tosylate)
Intervention: Drug: T-1101 (Tosylate)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195764
Other Study ID Numbers  ICMJE TAI-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taivex Therapeutics Corporation
Study Sponsor  ICMJE Taivex Therapeutics Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taivex Therapeutics Corporation
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP