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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.

Brief Summary:
A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: TQ-B3139 Phase 1

Detailed Description:
phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.

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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-B3139 in Patients With Advanced Cancer
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: TQ-B3139
TQ-B3139 p.o. qd
Drug: TQ-B3139
TQ-B3139 p.o. qd




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: each 28 days up to intolerance the toxicity or PD (up to 24 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 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
  • 18-65years,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

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): NCT03099330


Contacts
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Contact: Li Zhang, doctor 020-87343088 Zhangli6@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun-Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Zhang, doctor         
Contact: Su Li         
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: NCT03099330    
Other Study ID Numbers: TQ-B3139-I-0001
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: March 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms