Status:
UNKNOWN
A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- ≥18 years old
- Patients definitely diagnosed by pathology and/or cytology as advanced breast cancer with ER+、Her2-,who failed with standard endocrine therapy.
- ECOG PS:0-1,Survival is expected to be greater than 3 months
- 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
- Patients with malignant tumors, except for Cured cutaneous basal cell carcinoma and cervical carcinoma in situ
- Prior treatment with chemotherapy with cytotoxic drugs within 4 weeks, mitomycin C or nirtosocarbamide within 8 weeks
- Prior treatment with any anti-cancer therapy including hormone therapy radioimmunotherapy, molecular targeted therapy, immunotherapy or other biological therapy with 2 weeks
- Patients treated with other CDK4/6 inhibitors;
- 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;
- Previous history of stem cell or bowe marrow transplant;
- A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, intestinal obstruction, etc.)
- Patients with non-healing wounds or fractures, except for bone metastatics with pathologic frature
- 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)
- Patients who need to take CYP3A4 inhibitors or inducers from the screening period;
- Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders
- Patients with the urine protein≥2+, total ammount of 24 hours urinary protein determination\>1.0 grams;
- Patients with hyperactive/venous thrombosis events within 6 months,such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism
- Patients with active hepatitis b or c infection
- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
- Patients allergic to TQB3616 or any adjuvant in the capsule
- Patients who took part in other trials within 4 weeks;
- Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03850873
Start Date
March 1 2019
End Date
September 30 2021
Last Update
February 22 2019
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