A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics
Primary Purpose
Advanced Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TQB3616
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- ≥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 Criteria:
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQB3616
Arm Description
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily
Outcomes
Primary Outcome Measures
DLT
Dose-Limiting Toxicities
MTD
Maximum Tolerated Dose
Secondary Outcome Measures
Cmax
Maximum Observed Plasma Concentration
Tmax
Maximum Observed Plasma Concentration
t1/2
Terminal Half-life
AUC
Area Under the Curve
Full Information
NCT ID
NCT03850873
First Posted
February 20, 2019
Last Updated
February 20, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03850873
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.TQB3616 is taken by mouth daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB3616
Arm Type
Experimental
Arm Description
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily
Intervention Type
Drug
Intervention Name(s)
TQB3616
Intervention Description
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m,40mg,60mg,80mg,100mg,120mg once daily
Primary Outcome Measure Information:
Title
DLT
Description
Dose-Limiting Toxicities
Time Frame
Baseline up to 28 days
Title
MTD
Description
Maximum Tolerated Dose
Time Frame
Baseline up to 28 days
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum Observed Plasma Concentration
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
Title
Tmax
Description
Maximum Observed Plasma Concentration
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
Title
t1/2
Description
Terminal Half-life
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
Title
AUC
Description
Area Under the Curve
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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 Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZeFei Jiang, Doctor
Phone
010-66947171
Email
jiangzefei@csco.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yongmei Yin, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics
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