A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics

NCT ID: NCT02944864

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-13
• Study Completion Date: 2022-09-15

Brief Summary

To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQ-B3395

TQ-B3395 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type: EXPERIMENTAL

TQ-B3395

Intervention Type: DRUG

TQ-B3395 p.o. qd

Interventions

TQ-B3395

TQ-B3395 p.o. qd

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)
• 18-70 years,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

Exclusion Criteria

• 14 Days or more from the last cytotoxic therapy
• Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
• Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TQ-B3395-I-0001

Identifier Type: -

Identifier Source: org_study_id