Clinical trial · Interventional
Tolerance and Pharmacokinetics of TQ-B3233
To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research
NCT03453034CI-TRIAL-00031919unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-B3233 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ-B3233 capsule
- description
- QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.
- interventionNames
- Drug: TQ-B3233
Primary outcomes (6)
- measure
- maximum tolerated dose(MTD)
- timeFrame
- 28 Days
- measure
- dose-limiting toxicity(DLT)
- timeFrame
- 28 Days
- measure
- Peak Plasma Concentration(Cmax)
- timeFrame
- up to 28 Days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma. * 18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months; * Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 4 weeks, 6 weeks will be needed if agents were nitrocarbamide and mitomycin C; * 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 be voluntary and sign the informed consent before taking part in the study; Exclusion Criteria: * Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer; * Patients who had previously received specific BRAF inhibitors; * A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.) * Patients who participated in other anticancer drug clinical trials within 4 weeks ; * Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg,diastolic pressure≥90 mmHg); * Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias or cardiac insufficiency (including QTc≥480ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification); * Patients with non-healing wounds or fractures; * Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or MRI examination reminds patients with cerebral or soft meningeal diseases in the screening phase; * Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders; * Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy; * Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history; * Patients with thyroid dysfunction; * Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators; * Parents with hepatitis b surface antigen positive or HCV;
References
Publications (0)
Data not yet available
No reference posted for this study.