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A Phase I Study of TQB3616 on Tolerance and Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03850873
Recruitment Status : Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: TQB3616 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TQB3616
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily
Drug: TQB3616
TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m,40mg,60mg,80mg,100mg,120mg once daily




Primary Outcome Measures :
  1. DLT [ Time Frame: Baseline up to 28 days ]
    Dose-Limiting Toxicities

  2. MTD [ Time Frame: Baseline up to 28 days ]
    Maximum Tolerated Dose


Secondary Outcome Measures :
  1. 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 ]
    Maximum Observed Plasma Concentration

  2. 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 ]
    Maximum Observed Plasma Concentration

  3. 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 ]
    Terminal Half-life

  4. 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 ]
    Area Under the Curve



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850873


Contacts
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Contact: ZeFei Jiang, Doctor 010-66947171 jiangzefei@csco.org.cn
Contact: Yongmei Yin, Doctor

Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03850873    
Other Study ID Numbers: TQB3616-I-0001
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases