Advanced CancerPhase 1NCT03019276
A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics
A Phase 1 study testing TQ-B3101 in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- TQ-B3101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 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 70 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
- 18-70years,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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Hongming Pan, Doctor, panhongming63@163.com
About this study
Official title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3101 in Patients With Advanced Cancer
To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.
Read the detailed description
single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.
- Conditions
- Advanced Cancer
- Being tested
- TQ-B3101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3101Drug
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 .
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3101 | Experimental | TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: TQ-B3101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) of TQ-B3101
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
Measured: 48 weeks
The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3101
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
Pharmacokinetics of TQ-B3101 (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 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）
Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (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 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）
Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (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 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）
Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (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 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）
Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Pharmacokinetics of TQ-B3101 (in whole blood):Clearance（CL）
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）
Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Secondary outcomes (1)
Objective Response Rate(ORR)
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).
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.
- First posted12 Jan 2017 (estimated)
- Study start5 Jul 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019276
- Sponsor's protocol ID
- TQ-B3101-1-0001
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 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
Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z.
PubMed 37385995
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Tolerance and Pharmacokinetics of TQ-B3101 in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03019276
- Acronym / sponsor ID
- TQ-B3101-1-0001
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.
Detailed description
single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3101 | Experimental | Drug: TQ-B3101TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ-B3101Escalating 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 . | Drug | TQ-B3101 |
Primary outcome
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
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
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）
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）
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）
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）
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）
1 secondary outcome
Objective Response Rate(ORR)
Time frame: each 28 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 37385995Lu S, Pan H, Wu L, Yao Y, He J, Wang Y, Wang X, Fang Y, Zhou Z, Wang X, Cai X, Yu Y, Ma Z, Min X, Yang Z, Cao L, Yang H, Shu Y, Zhuang W, Cang S, Fang J, Li K, Yu Z, Cui J, Zhang Y, Li M, Wen X, Zhang J, Li W, Shi J, Xu X, Zhong D, Wang T, Zhu J. Efficacy, safety and pharmacokinetics of Unecritinib (TQ-B3101) for patients with ROS1 positive advanced non-small cell lung cancer: a Phase I/II Trial. Signal Transduct Target Ther. 2023 Jun 30;8(1):249. doi: 10.1038/s41392-023-01454-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQ-B3101 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 6 inclusion and 8 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 Hongming Pan, Doctor (0571-86960497, panhongming63@163.com), 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-B3101 (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 NCT03019276, 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.