CTRI/2022/04/041694进行中（未招募）不适用
A randomized, open label, multi-center, two-treatment, four-period, two-sequence, full replicate crossover, multiple dose, steady state Bioequivalence (BE) study of Pazopanib Tablets at a dose of 800 mg (4*200 mg tablets) of Oncogen Pharma (Malaysia) Sdn. Bhd. with Votrient® (Pazopanib) Tablets at a dose of 800 mg (4*200 mg tablets) of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in advanced renal cell carcinoma patients under fasting condition
Oncogen Pharma Malaysia Sdn Bhd18 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年4月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 18
- 主要终点
- To evaluate steady state bioequivalence of Pazopanib at a dosage of 800 mg (4x200 mg tablets) of Oncogen Pharma (Malaysia) Sdn. Bhd. compared to VOTRIENT® (Pazopanib) Tablets at a dose of 800 mg (4x200 mg tablets) of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in Advanced renal cell carcinoma patients under fasting condition.
研究概览
简要总结
OncogenPharma (Malaysia) Sdn. Bhd. has developed a generic product of the RLDVotrient® (Pazopanib) tablets. Oncogen Pharma (Malaysia) Sdn. Bhd. wants toconduct the study to characterize the pharmacokinetic profile of test productin comparison to the reference product in subjects with advanced renal cellcarcinoma in order to assess steady state bioequivalence.
Thestudy has been designed at a dose of 800 mg (4 * 200 mg tablets) in line withthe applicable USFDA’s Guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be considered eligible for the study based on the following criteria:
- •Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •Subjects aged greater than18 years with BMI at least 17.00 calculated as weight in kg per height in m
- •Subjects with confirmed diagnosis of advanced renal cell carcinoma includes, (a) Newly diagnosed subjects OR (b) Subjects who are already receiving stable dose of Pazopanib tablets of 800 mg per day for at least 15 days OR (c) Subjects with failure of first line treatment for advanced renal cell carcinoma and as per investigators discretion are eligible to receive Pazopanib tablets.
- •Subjects able to swallow and retain oral medication
- •Life expectancy of at least 3 months at the time of screening.
- •Acceptable hematology status: a.
- •Hemoglobin greater than or equal to 9.0 g per dL b.
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells per mm3 c.
- •Platelet count greater than or equal to 100,000 cells per mm3
- •Acceptable liver function: a.
- •Alanine aminotransferase (ALT) less than or equal to 2 X ULN (less than or equal to 5 X ULN in case of liver metastasis) b.
- •Bilirubin less than or equal to ULN
- •Subjects with Creatinine clearance greater than or equal to 30 mL per minute
- •Cardiac ejection fraction greater than or equal to 50 percent by echocardiogram (ECHO) within 28 days of first dose of Investigational Product.
- •Male subjects (including those who had a vasectomy) with female partners of reproductive potential must agree to use condoms from screening, during study and for at least two weeks after treatment discontinuation.
- •Female subjects of child bearing potential with negative serum pregnancy test at screening and at Day
- •Women of childbearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing acceptable methods of contraception from screening, during study and for at least two weeks after treatment discontinuation.
- •Acceptable methods of contraception are: a.
- •Oral or other (e.g. injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication b.
- •Intrauterine device or intrauterine system c.
- •Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) d.
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •Subjects will be excluded from the study based on the following criteria: 1.Known hypersensitivity to Pazopanib or the components of investigational product.
- •2.History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •3.Subjects with hypokalemia, hypomagnesaemia, long QT syndrome (QTc of > 450 msec in male or QTc of > 470 msec in female) or with relevant pre-existing cardiac disease at the time of screening 4.Subjects found with major vascular disease, arterial thromboembolic event or VTE in previous 6 months from the screening 5.Currently receiving or anticipated to receive any medications or substances that are strong inhibitors or inducers of the CYP3A4, strong inhibitors of P-gp or breast cancer resistance protein (BCRP); narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2D6 or CYP2C8; simvastatin, H2 receptor antagonist and PPIs.(Appendix B) 6.Subjects who are receiving or are anticipated to receive anti-coagulant therapy during study participation 7.Receiving any drugs known to prolong the QT interval within 4 weeks prior to first IP administration or during the study 8.Known central nervous system (CNS) metastasis.
- •9.History or presence of hemoptysis, cerebral hemorrhage, or clinically significant gastrointestinal hemorrhage in the past 6 months 10.History or presence of Thrombotic microangiopathy (TMA) or any other dermatological toxicity..
- •11.History or presence of gastrointestinal perforation or fistula 12.History or presence of Interstitial Lung Disease/Pneumonitis 13.History or presence of Posterior Reversible Encephalopathy Syndrome 14.Subjects who are at risk of TLS (e.g. rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration) 15.Subjects with ECOG Performance Status of >
- •16.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •17.Surgical or other non-healing wounds.
- •18.Subjects with positive serology for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency virus (HIV).
- •19.Subjects who tested positive for Coronavirus infection (COVID-19) 20.Subjects with current clinical or laboratory evidence of active infection.
- •21.History of other malignancies in the last 5 years 22.Have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), hemoglobin greater than or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (as per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
- •23.If subjects found positive in urine alcohol test 24.If subjects found positive in urine screen for drugs of abuse 25.Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •26.Loss of greater than or equal to 350mL (1 unit) of blood within 90 days before enrollment in the study.
- •27.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subjects to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •28.Lactating women.
结局指标
主要结局
To evaluate steady state bioequivalence of Pazopanib at a dosage of 800 mg (4x200 mg tablets) of Oncogen Pharma (Malaysia) Sdn. Bhd. compared to VOTRIENT® (Pazopanib) Tablets at a dose of 800 mg (4x200 mg tablets) of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in Advanced renal cell carcinoma patients under fasting condition.
时间窗: A total of fifty six (56) blood PK samples will be collected from each subject during the study participation at baseline, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 12:00 & 24 hours.
次要结局
- To monitor the adverse events and to assess the safety and tolerability in Advanced renal cell carcinoma patients under fasting condition.(A total of fifty six (56) blood PK samples will be collected from each subject during the study participation at baseline, 00.50, 01.00, 01.50, 02.00, 03.00, 04.00, 05.00, 06.00, 08.00, 12:00 & 24 hours.)
研究者
研究点 (18)
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