Back to resultsA Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TQB3602
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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.
Sites / Locations
- West China hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQB3602 capsule
Arm Description
TQB3602 capsule administered orally on day 1, 8, 15 in 28-day cycle.
Outcomes
Primary Outcome Measures
Dose-limiting toxicity (DLT)
Subjects appear the following toxic reaction relate to the drug after treatment within 28 days ：III °or above of non-hematological toxicity, IV° hematological toxicity , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding.
Secondary Outcome Measures
Cmax
Cmax is the maximum plasma concentration of TQB3602 or metabolite(s).
Tmax
To characterize the pharmacokinetics of TQB3602 by assessment of time to reach maximum plasma concentration.
AUC0-t
To characterize the pharmacokinetics of TQB3602 by assessment of area under the plasma concentration time curve from zero to infinity.
Full Information
NCT ID
NCT04275583
First Posted
February 16, 2020
Last Updated
June 16, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04275583
Brief Title
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
Official Title
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 28, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQB3602 capsule
Arm Type
Experimental
Arm Description
TQB3602 capsule administered orally on day 1, 8, 15 in 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
TQB3602
Intervention Description
This is a kind of proteasome inhibitor.
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Subjects appear the following toxic reaction relate to the drug after treatment within 28 days ：III °or above of non-hematological toxicity, IV° hematological toxicity , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding.
Time Frame
Baseline up to 28 days
Secondary Outcome Measure Information:
Title
Cmax
Description
Cmax is the maximum plasma concentration of TQB3602 or metabolite(s).
Time Frame
0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.
Title
Tmax
Description
To characterize the pharmacokinetics of TQB3602 by assessment of time to reach maximum plasma concentration.
Time Frame
0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.
Title
AUC0-t
Description
To characterize the pharmacokinetics of TQB3602 by assessment of area under the plasma concentration time curve from zero to infinity.
Time Frame
0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Niu, Doctor
Phone
028-85423046
Email
tingniu@sina.com
Facility Information:
Facility Name
West China hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Niu, Doctor
Phone
028-85423046
Email
tingniu@sina.com
First Name & Middle Initial & Last Name & Degree
Ting Niu, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
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