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

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

Study Overview

• Status: Unknown
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: TQ-B3139 capsules

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nong Yang, Doctor; Phone Number: 0731-89762320; Email: yangnongpi@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
      • Principal Investigator: Nong Yang, Doctor
      • Contact: Nong Yang, Doctor; Phone Number: 0731-89762320; Email: yangnongpi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 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.	Drug: TQ-B3139 capsules; TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
Experimental: Cohort 2; 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.	Drug: TQ-B3139 capsules; TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
AUC0-∞	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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
Objective Response Rate (ORR)	Percentage of participants achieving complete response (CR) and partial response (PR).	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.	up to 24 months
Disease control rate (DCR)	Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).	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.	up to 24 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TQ-B3139-I-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No