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.
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
Interventions
Drug | Synonyms | Arms |
---|
TQB3616 | | TQB3616 |
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
Name | Type | Description | Interventions |
---|
TQB3616 | Experimental | TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily | |
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. |
Last Updated
February 22, 2019