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Advanced CancerPhase 1NCT03099330

A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics

A Phase 1 study testing TQ-B3139 in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Advanced Cancer
What is being tested?
TQ-B3139
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
19 Jul 2017to Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Li Zhang, doctor contact

020-87343088

Zhangli6@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun-Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Li Zhang, doctor

    Su Li

    Recruiting

Other trials in China

About this study

Official title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3139 in Patients With Advanced Cancer

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

Read the detailed description

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

Conditions
Advanced Cancer
Being tested
TQ-B3139

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQ-B3139Drug

    TQ-B3139 p.o. qd

Study groups in NCT03099330
Study groupRoleWhat they receive
TQ-B3139ExperimentalTQ-B3139 p.o. qd
Receives: Drug: TQ-B3139

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum tolerated dose (MTD) of TQ-B3139

    The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

    Measured: 48 weeks

  2. The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3139

    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

    Measured: For 4 weeks for DLTs

  3. Pharmacokinetics of TQ-B3139 (in whole blood):Peak Plasma Concentration(Cmax)

    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）.

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  4. Pharmacokinetics of TQ-B3139 (in whole blood):Peak time（Tmax）

    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）.

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  5. Pharmacokinetics of TQ-B3139 (in whole blood):Half life（t1/2）

    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）.

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  6. Pharmacokinetics of TQ-B3139 (in whole blood):Area under the plasma concentration versus time curve (AUC)

    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）.

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  7. Pharmacokinetics of TQ-B3139 (in whole blood):Clearance（CL）

    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）.

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    Measured: each 28 days up to intolerance the toxicity or PD (up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start19 Jul 2017
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099330
Sponsor's protocol ID
TQ-B3139-I-0001
Status last verified
Mar 2017
First submitted
28 Mar 2017
Last updated
18 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ma Y, Zhao H, Xue J, Liu L, Yang N, Zhang Y, Yang H, Hong S, Xiong Y, Zhang Z, Zeng L, Pan H, Zhou C, Zhang Y, Wang X, Han X, Wan X, Shao Y, Liu J, Yang Y, Huang Y, Zhao Y, Fang W, Li S, Zhang L. First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements. Eur J Cancer. 2022 Sep;173:238-249. doi: 10.1016/j.ejca.2022.06.037. Epub 2022 Aug 5.

    PubMed 35940055

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQ-B3139 in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Zhang, doctor (020-87343088, Zhangli6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD) of TQ-B3139 (time frame: 48 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03099330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.

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