A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule

NCT ID: NCT04275583

Last Updated: 2020-06-17

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

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2022-12-30

Brief Summary

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This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3474 in patients with advanced malignant tumors.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB3602 capsule

TQB3602 capsule administered orally on day 1, 8, 15 in 28-day cycle.

Group Type EXPERIMENTAL

TQB3602

Intervention Type DRUG

This is a kind of proteasome inhibitor.

Interventions

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TQB3602

This is a kind of proteasome inhibitor.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1.Understood and signed an informed consent form. 2.18 and 75 years old , male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

4\. Life expectancy ≥12 weeks. 5. Relapsed/refractory multiple myeloma had received at least two treatment methods.

6\. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

Exclusion Criteria

* 1\. Hypersensitivity to TQB3602 or its excipient. 2. Has peripheral nerve diseases ≥ grade 2. 3. Has diarrhea grade \> 1 during screening period. 4. Has received chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic antitumor therapies within 14 days before the first dose.

5\. Has received ixazomib and less than 5 half-life before the first dose. 6. Has received allogeneic stem cell transplant. 7. Pregnant or lactating women. 8. Has participated in other clinical trials within 4 weeks before participating in this trial.

9\. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West China hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Niu, Doctor

Role: CONTACT

028-85423046

Facility Contacts

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Ting Niu, Doctor

Role: primary

028-85423046

Other Identifiers

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TQB3602-I-01

Identifier Type: -

Identifier Source: org_study_id

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