A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

NCT ID: NCT03850873

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-09-30

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.

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3616

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

Group Type: EXPERIMENTAL

TQB3616

Intervention Type: DRUG

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

Interventions

TQB3616

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

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

ZeFei Jiang, Doctor

Role: CONTACT

jiangzefei@csco.org.cn

010-66947171

Yongmei Yin, Doctor

Role: CONTACT

Other Identifiers

TQB3616-I-0001

Identifier Type: -

Identifier Source: org_study_id