A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

Advanced Breast Cancer Clinical Trial

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03850873
• Other study ID #: TQB3616-I-0001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: ZeFei Jiang, Doctor
• Phone: 010-66947171
• Email: jiangzefei[@]csco.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• TQB3616
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m,40mg,60mg,80mg,100mg,120mg once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT	Dose-Limiting Toxicities	Baseline up to 28 days
Primary	MTD	Maximum Tolerated Dose	Baseline up to 28 days
Secondary	Cmax	Maximum Observed Plasma Concentration	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
Secondary	Tmax	Maximum Observed Plasma Concentration	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
Secondary	t1/2	Terminal Half-life	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
Secondary	AUC	Area Under the Curve	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