Advanced Solid TumorsPhase 1NCT04675060
Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules
A Phase 1 study testing TQ-B3139 capsules in people with Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- TQ-B3139 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2021to 1 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
- 2. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
- 4. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
- 6.Understood and signed an informed consent form.
Who cannot join
- 1. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
- 4. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
- 5. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.
- 9. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.
- 12. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
- 13. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.
- 14. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Nong Yang, Doctor, 0731-89762320, yangnongpi@163.com
Nong Yang, Doctor
About this study
Official title: A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor
This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor
- Conditions
- Advanced Solid Tumors
- Being tested
- TQ-B3139 capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3139 capsulesDrug
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | TQ-B3139 capsules administered single dose of 600 mg under fasted conditions in day 1 followed by single dose of 600 mg with a high-fat meal in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily. Receives: Drug: TQ-B3139 capsules |
| Cohort 2 | Experimental | TQ-B3139 capsules administered single dose of 600 mg with a high-fat meal in day 1 followed by single dose of 600 mg under fasted conditions in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily. Receives: Drug: TQ-B3139 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.
Measured: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
AUC0-∞
To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Cmax
Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).
Measured: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Secondary outcomes (6)
Tmax
To characterize the pharmacokinetics of TQ-B3139 by assessment of time to reach maximum plasma concentration.
Measured: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
t1/2
t1/2 is time it takes for the blood concentration of TQ-B3139 or metabolite(s) to drop by half.
Measured: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 24 months
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: up to 24 months
Disease control rate (DCR)
Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: up to 24 months
Duration of response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: 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 posted19 Dec 2020
- Study start23 Feb 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04675060
- Sponsor's protocol ID
- TQ-B3139-I-02
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT04675060
- Acronym / sponsor ID
- TQ-B3139-I-02
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 19 Dec 2020 (actual)
- 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.
This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TQ-B3139 capsulesTQ-B3139 capsules administered single dose of 600 mg under fasted conditions in day 1 followed by single dose of 600 mg with a high-fat meal in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily. |
| Cohort 2 | Experimental | Drug: TQ-B3139 capsulesTQ-B3139 capsules administered single dose of 600 mg with a high-fat meal in day 1 followed by single dose of 600 mg under fasted conditions in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
- 2. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
- 4. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
- 6.Understood and signed an informed consent form.
Key exclusion criteria (7 listed)
- 1. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
- 4. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
- 5. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.
- 9. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.
- 12. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
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-B3139 capsulesTQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle. | Drug | Cohort 1, Cohort 2 |
Primary outcome
AUC0-t
Time frame: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.
AUC0-∞
Time frame: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.
Cmax
Time frame: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).
6 secondary outcomes
Tmax
Time frame: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
t1/2
Time frame: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Objective Response Rate (ORR)
Time frame: up to 24 months
Progression-free survival (PFS)
Time frame: up to 24 months
Disease control rate (DCR)
Time frame: up to 24 months
Duration of response (DOR)
Time frame: 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 1 Apr 2021.
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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-B3139 capsules in people with Advanced Solid Tumors, 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 4 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 1 Apr 2021. 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 Nong Yang, Doctor (0731-89762320, yangnongpi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021.