CTRI/2026/03/106003招募中不适用
An Open label balanced randomized two treatment two period two sequence multiple dose multi center steady state crossover oral bioequivalence study of Dabrafenib Mesylate capsules 150 mg twice daily Rising Pharma Holdings Inc USA with Tafinlar Dabrafenib 75mg 4 capsules of Novartis Pharmaceuticals Corporation East Hanover New Jersey 07936 USA along with Trametinib 2 mg for the treatment of patients with BRAFV600E or V600K mutations who are already receiving a stable dose of Dabrafenib mesylate capsules under fasting conditions
Rising Pharma Holdings, Inc.,17 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年4月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 17
研究概览
简要总结
Rising Pharma Holdings is seeking marketing authorization approval for Dabrafenib Mesylate capsules dose of 150 mg (twice daily) in USFDA for which demonstration of bioequivalence in patient population for the treatment of patients with BRAFV600E or V600K mutations who are already receiving a stable dose of Dabrafenib Mesylate capsules under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- •1.Men or woman aged equal or more than 18 years.
- •2.Histologically confirmed diagnosis of adult patients with a BRAFV600E or V600K mutations detection test.
- •3.Participants who are already receiving a stable dose of Dabrafenib Mesylate capsules will be included in the study.
- •4.Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
- •5.Karnofsky performance status (KPS) equal or more than 70 Percentage.
- •6.Women of childbearing potential (WOCBP) and men with reproductive potential must agree to use effective contraception during the study and at least two weeks after the last dose.
- •WOCBP must have a negative serum pregnancy test within 14 days prior to randomization.
- •7.Eastern Cooperative Oncology Group (ECOG) Performance Status equal or less than
- •8.Life expectancy of greater than at least 3-6 months.
- •9.Left ventricular ejection fraction same or more than institutional lower limit of normal (LLN) by echocardiogram (ECHO) 10.Patients must not receive any other investigational agents while on study or within four weeks prior to registration.
- •11.Patients must not have evidence of interstitial lung disease or pneumonitis.
- •12.Ability to understand and the willingness to sign a written informed consent document.
- •13.Adequate function of major organs, meeting the following criteria: •Hematologic parameters: WBC equal or more than 4.0 × 10^9per litre ANC equal or more than 1.5 × 10^9per litre PLT equal or more than 100 × 10^9per litre Hb equal or more than 90 gram per litre.
- ••Biochemical parameters: Serum albumin equal or more than 3.0 gram/ desi litre (30 gram per litre) TBIL equal or less 1.5×ULN ALT and AST equal or less than 2.5×ULN BUN and creatinine equal or less than 1.5×ULN or estimated creatinine clearance equal or more than 60 milli litre /minute (by Cockcroft-Gault formula).
- ••Coagulation: INR or PT equal or less than 1.5×ULN for subjects on anticoagulation therapy, PT must be within the therapeutic range defined by the medication.
排除标准
- •Exclusion Criteria: Patient presenting with any of the following will not be included in the study and the reason for exclusion from the study will be documented: 1.Patients with colorectal cancer and wild type BRAF solid tumors will not be enrolled in the study.
- •2.Any prior use of BRAF inhibitors (BRAFi) MEK inhibitors (MEKi) or ipilimumab in the advanced or metastatic setting.
- •3.Exclude patients who require dosage modification or with expected changes in concomitant medications (e.g. trametinib) that may potentially affect the pharmacokinetics of Dabrafenib Mesylate during the study.
- •4.Patient with ocular melanoma are not eligible.
- •5.Any major surgery extensive radiotherapy chemotherapy with delayed toxicity biologic therapy or immunotherapy within the last 21 days.
- •Chemotherapy given daily or weekly without the potential for delayed toxicity within the last 14 days.
- •6.Current use of any prohibited medication.
- •Participants taking corticosteroids (equal or more than 10 mg of prednisone or equivalent).
- •Exceptions may be discussed with the overall PI on a case by case basis.
- •Participants with a personal or family history of long QT syndrome.
- •Historical or current evidence of significant hematologic hepatic neurologic psychiatric renal or other diseases that in the opinion of the investigator would put the Patient at risk through study participation or would affect the study analyses if the disease exacerbates during the study.
- •History of another malignancy with the exception of patients who have been disease-free for 3 years or patients with a history of completely resected non-melanoma skin cancer.
- •11.Any serious and or unstable pre-existing medical psychiatric disorder or other conditions that could interfere with patient safety obtaining informed consent or complying with study procedures.
- •12.Known Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
- •13.History or evidence of cardiovascular risk including any of the following: • History or evidence of current clinically significant uncontrolled arrhythmia with the exception of atrial fibrillation that will be controlled for more than 30 days prior to randomization.
- ••History of (within 6 months prior to randomization) acute coronary syndromes (including myocardial infarction and unstable angina) coronary angioplasty or stenting.
- ••History or evidence of current equal or more than Class II congestive heart failure as defined by New York Heart Association (NYHA).
- ••Significant uncontrolled or active cardiovascular disease specifically including but not restricted to: History of clinically significant (as determined by the treating physician) atrial arrhythmia; or any ventricular arrhythmia History of congenital long QT syndrome.
- •Abnormal QTc (equal or more than 450 msec in males and equal or more than 470 msec in females) Ejection fraction equal or less than 50 percentage as assessed by echocardiogram.
- ••History of arterial thrombotic disease specifically including but not restricted to: Myocardial infarction or unstable angina cerebrovascular event (CVA) or transient ischemic attack (TIA) Peripheral vascular disease or claudication.
- ••Uncontrolled hypertension (Diastolic blood pressure more than 100 mmHg Systolic blood pressure more than 150 mmHg).
- •14.History of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) within 6 months of study entry.
- •Note: Participants enrolled after this window must be on appropriate therapeutic anticoagulation.
- •15.History of interstitial lung disease or pneumonitis.
- •16.History of or current evidence or risk of retinal vein occlusion (RVO) or central serious retinopathy (CSR) predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension uncontrolled hypertension uncontrolled diabetes mellitus or history of hyper viscosity or hypercoagulability syndromes) or visible retinal pathology as assessed by ophthalmic exam considered a risk factor for RVO or CSR such as: Evidence of new optic disc cupping.
- ••Intraocular pressure more than 21 mm Hg as measured by tonography.
- •17.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or excipients.
- •18.Patient who are pregnant and breast feeding
- •Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 90 days prior to visit
- •20.Inability to provide informed consent.
- •21.Patients with presence of cutaneous squamous cell carcinoma (cuSCC) (including keratoacanthoma) and non-cutaneous malignancies.
- •22.Patients with presence of hemorrhagic events including major hemorrhagic events and fatal hemorrhages.
- •Patients with presents of Deep vein thrombosis (DVT) or pulmonary embolism (PE).
- •26.Patients with presence of severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS).
- •27.Participants with impairment of GI function or GI disease that may significantly alter the absorption of Dabrafenib Mesylate in the opinion of the treating investigator (e.g. ulcerative diseases uncontrolled nausea vomiting diarrhea malabsorption syndrome small bowel resection).
- •31.Any other condition that in the opinion of the investigator may compromise the safety compliance of the patient or would preclude the patient from successful completion of the study.
- •32.Blood loss or whole blood donation within 90 days prior to drug administration.
- •Positive results for drugs of abuse (alcohol benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates) in urine.
研究者
Dr Suman Avula
Jeevan Scientific Technology Limited
研究点 (17)
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