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

CTTQ

Status and phase: Terminated; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: TQ-B3395

Study type: Interventional

Funder types: Industry

Identifiers

NCT02944864

TQ-B3395-I-0001

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

TQ-B3395

Experimental group

Description:

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

Treatment:

Drug: TQ-B3395