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

Phase 1

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TQ-B3139 capsules

• Registration Number: NCT04675060
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-19
• Study Start: 2021-02-23
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

  3. 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) .

  2. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.

  3. 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.

  4. 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.

  5. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.

  6. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.

  7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	TQ-B3139 capsules	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.
Cohort 2	TQ-B3139 capsules	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.

Primary Outcome Measures

Name	Time	Method
AUC0-t	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-∞	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	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China