Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 8:58 AM
Study NCT ID:
NCT03453034
Status:
UNKNOWN
Last Update Posted:
2018-03-05
First Post:
2017-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Pharmacokinetics of TQ-B3233
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2017-12-23', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}, {'measure': 'Peak time(Tmax)', 'timeFrame': 'up to 28 Days'}, {'measure': 'Half life(t1/2)', 'timeFrame': 'up to 28 Days'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'up to 28 Days'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TQ-B3233', 'tumor', 'toleration', 'pharmacokinetics'], 'conditions': ['Tumor']}, 'descriptionModule': {'briefSummary': 'Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.', 'detailedDescription': 'The maximum tolerated dose (MTD) of TQ-B3233 \\[ Time Frame: 48 weeks \\] \\[ Designated as safety issue: Yes \\]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.\n\nPharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.\n* 18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months;\n* 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;\n* Main organs function is normal;\n* 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;\n* Patients should be voluntary and sign the informed consent before taking part in the study;\n\nExclusion Criteria:\n\n* Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer;\n* Patients who had previously received specific BRAF inhibitors;\n* A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)\n* Patients who participated in other anticancer drug clinical trials within 4 weeks ;\n* Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg，diastolic pressure≥90 mmHg);\n* 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);\n* Patients with non-healing wounds or fractures;\n* 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;\n* Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders;\n* Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy;\n* Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;\n* Patients with thyroid dysfunction;\n* Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;\n* Parents with hepatitis b surface antigen positive or HCV;"}, 'identificationModule': {'nctId': 'NCT03453034', 'briefTitle': 'Tolerance and Pharmacokinetics of TQ-B3233', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research', 'orgStudyIdInfo': {'id': 'TQ-B3233-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'TQ-B3233', 'type': 'DRUG', 'description': 'QD or BID in different stage of this research', 'armGroupLabels': ['TQ-B3233 capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Guo, doctor', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '010-88196317'}], 'facility': 'Beijing cancer hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guo Jun, doctor', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '010-88196317'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}