Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules

Advanced Solid Tumors Clinical Trial

Official title:

A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675060
• Other study ID #: TQ-B3139-I-02
• Status: Recruiting
• Phase: Phase 1
• Start date: February 23, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: December 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Nong Yang, Doctor
• Phone: 0731-89762320
• Email: yangnongpi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• TQ-B3139 capsules
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.	0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Primary	AUC0-8	To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.	0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Primary	Cmax	Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).	0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Secondary	Tmax	To characterize the pharmacokinetics of TQ-B3139 by assessment of time to reach maximum plasma concentration.	0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Secondary	t1/2	t1/2 is time it takes for the blood concentration of TQ-B3139 or metabolite(s) to drop by half.	0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Secondary	Objective Response Rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	up to 24 months
Secondary	Progression-free survival (PFS)	PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.	up to 24 months
Secondary	Disease control rate (DCR)	Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).	up to 24 months
Secondary	Duration of response (DOR)	DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.	up to 24 months