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A Phase I Study of TQ-B3139 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099330
Recruitment Status : Unknown
Verified March 2017 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 4, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date September 18, 2017
Actual Study Start Date  ICMJE July 19, 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • The maximum tolerated dose (MTD) of TQ-B3139 [ Time Frame: 48 weeks ]
    The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
  • The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3139 [ 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
  • Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28(D means Day).
  • Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28(D means Day).
  • Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28(D means Day).
  • Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28(D means Day).
  • Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28(D means Day).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
Objective Response Rate (ORR) [ Time Frame: each 28 days up to intolerance the toxicity or PD (up to 24 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics
Official Title  ICMJE Phase I Study of Tolerance and Pharmacokinetics of TQ-B3139 in Patients With Advanced Cancer
Brief Summary A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer
Detailed Description phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: TQ-B3139
TQ-B3139 p.o. qd
Study Arms  ICMJE Experimental: TQ-B3139
TQ-B3139 p.o. qd
Intervention: Drug: TQ-B3139
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological documentation of Advanced solid tumors
  • Lack of the standard treatment or treatment failure
  • 18-65years,ECOG PS:0-1,Life expectancy of more than 3 months
  • Patients with anti-treatment or surgery within 4 weeks
  • 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 participated in other anticancer drug clinical trials within 4 weeks
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099330
Other Study ID Numbers  ICMJE TQ-B3139-I-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor  ICMJE Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP