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A Study of TQ-B3101 Capsules ...

A Study of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2021-09-30

Brief Summary

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The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant tumor.

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Detailed Description

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Conditions

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Advanced Malignant Tumor

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQ-B3101 capsules

TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.

Group Type EXPERIMENTAL

TQ-B3101

Intervention Type DRUG

TQ-B3101 is a ALK inhibitor.

Interventions

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TQ-B3101

TQ-B3101 is a ALK inhibitor.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.

2\. Understood and signed an informed consent form. 3. Histologically or cytologically confirmed advanced malignant solid tumors. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception.

Exclusion Criteria

* 1\. Has multiple factors affecting oral medication. 2. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1. 3. Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors.

4\. Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.

5\. Has cardiovascular and cerebrovascular diseases. 6. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.

7\. Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.

8\. Active hepatitis, HIV positive, syphilis positive. 9. Has a history of psychotropic substance abuse. 10. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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