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A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT03019276
Recruitment Status : Unknown
Verified January 2017 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Recruiting
First Posted : January 12, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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Brief Summary:
To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: TQ-B3101 Phase 1

Detailed Description:
single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3101 in Patients With Advanced Cancer
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: TQ-B3101
TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
 Drug: TQ-B3101
Escalating doses of TQ-B3101 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 100 mg to 500 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days .


Outcome Measures
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Primary Outcome Measures :
  1. The maximum tolerated dose (MTD) of TQ-B3101 [ Time Frame: 48 weeks ]
    The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

  2. The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3101 [ Time Frame: For 4 weeks for DLTs ]
    Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever

  3. Pharmacokinetics of TQ-B3101 (in whole blood):Peak Plasma Concentration(Cmax) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）

  4. Pharmacokinetics of TQ-B3101 (in whole blood):Peak time（Tmax） [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）

  5. Pharmacokinetics of TQ-B3101 (in whole blood):Half life（t1/2） [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）

  6. Pharmacokinetics of TQ-B3101 (in whole blood):Area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）

  7. Pharmacokinetics of TQ-B3101 (in whole blood):Clearance（CL） [ Time Frame: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) ]
    Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）


Secondary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: each 28 days up to intolerance the toxicity or PD (up to 24 months) ]
    Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documentation of Advanced solid tumors
  • Lack of the standard treatment or treatment failure
  • 18-70years,ECOG PS:0-1,Life expectancy of more than 3 months
  • Main organs function is normal
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  • Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

  • Patients with treatment failure by ALK/ROS1 inhibitor
  • Patients with anti-teratment,radiotherapy or surgery within 4 weeks
  • Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week
  • Blood pressure unable to be controlled(systolic pressure>140 mmHg，diastolic pressure>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
  • Patients with non-healing wounds or fractures
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Contacts and Locations
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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): NCT03019276


Contacts
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Contact: Hongming Pan, Doctor 0571-86960497 panhongming63@163.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Hongming Pan, Doctor       panhongming63@163.com   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03019276    
Other Study ID Numbers: TQ-B3101-1-0001
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Neoplasms