Clinical Trials /

A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

NCT03850873

Description:

TQB3616 may work in cancer by stopping cancer cells from multiplying.TQB3616 is in a new class of drugs called CDK inhibitors.This research study is the first time that TQB3616 will be given to people.TQB3616 is taken by mouth daily.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics
  • Official Title: A Phase I Clinical, Tolerance and Pharmacokinetic Evaluation of 1 Schedules of Oral TQB3616,A Cyclin-Dependent Kinase Inhibitor ,In Patients With Advanced Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: TQB3616-I-0001
  • NCT ID: NCT03850873

Conditions

  • Advanced Breast Cancer

Interventions

DrugSynonymsArms
TQB3616TQB3616

Purpose

TQB3616 may work in cancer by stopping cancer cells from multiplying.TQB3616 is in a new class of drugs called CDK inhibitors.This research study is the first time that TQB3616 will be given to people.TQB3616 is taken by mouth daily.

Trial Arms

NameTypeDescriptionInterventions
TQB3616ExperimentalTQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily
  • TQB3616

Eligibility Criteria

        Inclusion Criteria:

          1. ≥18 years old

          2. Patients definitely diagnosed by pathology and/or cytology as advanced breast cancer
             with ER+Her2-,who failed with standard endocrine therapy.

          3. ECOG PS:0-1,Survival is expected to be greater than 3 months

          4. Main organs function is normal or must meet the following criteria(within past 14
             days) 1) hemoglobin≥90g/L; neutrophils≥1.5 x109/L; Platelets≥100 x109/L
             2)Albumin≥29g/L; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic
             transaminase(AST) and alanine transaminase(ALT)≤2.5 ULN, and ≤ 5 x ULN with hepatic
             metastasis;serum creatinine ≤1.5 xULN,creatinine clearance >60ml/min;
             Triglyceride≤3.0mmol/L, cholesterol≤7.75mmol/L

        3)Doppler ultrasound evaluation: Left ventricular ejection fraction(LVEF)≥50% 5.Patients
        should be voluntary and sign the informed consent before taking part in the study

        Exclusion Criteria:

          1. Patients with malignant tumors, except for Cured cutaneous basal cell carcinoma and
             cervical carcinoma in situ

          2. Prior treatment with chemotherapy with cytotoxic drugs within 4 weeks, mitomycin C or
             nirtosocarbamide within 8 weeks

          3. Prior treatment with any anti-cancer therapy including hormone therapy
             radioimmunotherapy, molecular targeted therapy, immunotherapy or other biological
             therapy with 2 weeks

          4. Patients treated with other CDK4/6 inhibitors;

          5. Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or
             MRI examination reminds patients with cerebral or soft meningeal diseases in the
             screening phase;

          6. Previous history of stem cell or bowe marrow transplant;

          7. A variety of factors that affect oral medication (such as inability to swallow,
             gastrointestinal resection, intestinal obstruction, etc.)

          8. Patients with non-healing wounds or fractures, except for bone metastatics with
             pathologic frature

          9. Previous history of uncontrolled cardiovascular disease including: a) Grade 3 or
             higher congestive heart failure (NYHA Classification);b)unstable angina pectoris or
             newly developped angina pectoris within 3months before the trial; c) Myocardial in
             farction or stroke occured within 6 months prior to intiation of trial; d) Arrhythmias
             requiring antiarrhythmic treatment(beta-blocker or digoxin is permitted)

         10. Patients who need to take CYP3A4 inhibitors or inducers from the screening period;

         11. Patients with drug abuse history or unable to get rid of drugs or Patients with mental
             disorders

         12. Patients with the urine protein≥2+, total ammount of 24 hours urinary protein
             determination>1.0 grams;

         13. Patients with hyperactive/venous thrombosis events within 6 months,such as
             cerebrovascular accidents (including temporary ischemic attack), deep venous
             thrombosis and pulmonary embolism

         14. Patients with active hepatitis b or c infection

         15. Patients with immunodeficiency, including HIV positive or other acquired, congenital
             immunodeficiency disease, or organ transplant history;

         16. Patients allergic to TQB3616 or any adjuvant in the capsule

         17. Patients who took part in other trials within 4 weeks;

         18. Patients with concomitant diseases which could seriously endanger themselves or those
             who won't complete the study according to investigators;
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:DLT
Time Frame:Baseline up to 28 days
Safety Issue:
Description:Dose-Limiting Toxicities

Secondary Outcome Measures

Measure:Cmax
Time Frame:Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28
Safety Issue:
Description:Maximum Observed Plasma Concentration
Measure:Tmax
Time Frame:Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28
Safety Issue:
Description:Maximum Observed Plasma Concentration
Measure:t1/2
Time Frame:Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28
Safety Issue:
Description:Terminal Half-life
Measure:AUC
Time Frame:Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28
Safety Issue:
Description:Area Under the Curve

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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