A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TQB3602 capsule TQB3602 capsule administered orally on day 1, 8, 15 in 28-day cycle. |
Drug: TQB3602
This is a kind of proteasome inhibitor.
|
Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicity (DLT) [Baseline up to 28 days]
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 [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.]
Cmax is the maximum plasma concentration of TQB3602 or metabolite(s).
- Tmax [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.]
To characterize the pharmacokinetics of TQB3602 by assessment of time to reach maximum plasma concentration.
- AUC0-t [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.]
To characterize the pharmacokinetics of TQB3602 by assessment of area under the plasma concentration time curve from zero to infinity.
Eligibility Criteria
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
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Life expectancy ≥12 weeks. 5. Relapsed/refractory multiple myeloma had received at least two treatment methods.
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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:
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- 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.
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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.
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According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China hospital, Sichuan University | Chengdu | Sichuan | China | 610000 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TQB3602-I-01