Health Condition 1: C49A- Gastrointestinal stromal tumor
Conditions
Interventions
Intervention1: Sunitinib Malate Capsules 50 mg: An oral dose (single capsule) of either the test product Sunitinib
Malate Capsules 50 mg or reference product ‘SUTENT®’ (Sunitinib
Malate) Capsules 50
Sponsors
Oncogen Pharma Malaysia Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: Subject will be eligible for inclusion in this study only if all of the following criteria apply: 1) Male or non-pregnant or non-lactating female aged 18 - 65 years (both inclusive). 2) Disease population: • Subject with documented diagnosis of gastrointestinal stromal tumors after disease progression or intolerance to imatinib mesylate; or • Subject with documented clinical diagnosis of advanced renal cell carcinoma 3) Subject who are already taking and stable on Sunitinib 50 mg daily for at least 28 days or eligible to receive Sunitinib. 4) Subject must have an eastern cooperative oncology group (ECOG) performance status of = 2. 5) Subject with Body Mass Index (BMI) = 18 to = 30kg/m2. BMI values should be rounded to the nearest integer (e.g. 30.4 rounds down to 30, while 17.5 rounds up to 18). 6) Subject with adequate organ function defined as: • Hemoglobin of = 9.0 g/dL, • Platelet count = 100,000/mm3 • ANC ? 1500/µL, • Serum creatinine = 1.5 times the upper limit of normal, and • Left ventricular ejection fraction (LVEF) > lower limit of normal. • Alkaline phosphatase = 2.5 times the upper limit of normal, • AST and ALT = 2.5 times the upper limit of normal, • Total Bilirubin = 1.5 times the upper limit of normal, • PT & aPTT = 1.5 times the upper limit of normal, • Urine protein 7) Male subject with female partner of reproductive potential agrees to use acceptable contraceptive method from screening to 7 weeks after last dose of investigational product. 8) Female subject agrees to use acceptable contraceptive method from screening to 4 weeks after last dose of investigational product. 9) Subject should have recovered from any toxic effects of previous therapy. 10) Willing to provide written informed consent to participate in the study. 11) Able to comply with all the study requirements
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria should be excluded: 1) Known hypersensitivity to Sunitinib or any of its excipients. 2) Subject having signs and symptoms suggestive of COVID-19 (such as fever, cough, and difficulty in breathing). 3) Diagnosis of any secondary malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri. 4) Subject with history of any of the following condition within 12 months prior to IP administration •Severe/unstable angina, •Myocardial infarction, •Symptomatic congestive heart failure, or Cerebrovascular accident. 5) Subject with following ongoing cardiac dysrhythmias Atrial fibrillation of any grade, or QTc interval prolongation for females QTc interval will be measured as per Bazetts formula. 6) Subject with history of the cardiac and vascular conditions such as cardiac angioplasty, stenting, any significant ECG changes within 6 months prior to screening. 7) Subject receiving any drugs known to prolong the QT interval within 4 weeks prior to study or during the study. 8) Subject with poorly controlled hypertension (systolic blood pressure of = 150 mmHg or diastolic blood pressure of = 95 mmHg, despite optimal medical management). 9) Subject on drugs known to be inducer or inhibitor of CYP3A4 enzyme. Note: If the subject was on any of the prohibited medications, sufficient wash out period (of at least 5 half-lives) must have elapsed since the last dose of such drug and the first dose of study medication. 10) Major surgery of the gastrointestinal tract, the liver or kidney within 6 months prior to randomization which may affect the pharmacokinetics of Sunitinib. 11) Anticipated invasive dental procedures within 3 weeks of therapy. 12) Subject with history of reversible posterior leukoencephalopathy syndrome, dermatologic toxicities, thrombotic microangiopathy, haemorrhagic events. 13) Expected changes in concomitant medications during study. 14) Subject unable to swallow orally administered medication or has gastrointestinal disorders likely to interfere with absorption of the study medication. 15) Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of randomization. 16) Ingestion of any alcoholic, caffeine or xanthine containing food or beverage, recreational drugs, cigarettes and tobacco containing products within the 48 hours prior to randomization. 17) A positive test result for Hepatitis (includes subtypes B & C), HIV and/or Syphilis (RPR/VDRL). 18) Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) within 90 days prior to receiving the first dose of study drug. 19) Subject with history of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture. 20) Subject with history of drug or alcohol dependency or abuse within the last 2 years of screening. 21) Subject received any investigational drug within the past 3 months. 22) Subjects who are institutionalized. 23) Other severe, acute, or chronic medical condition or laboratory abnormalities which in the opinion of the investigator increase risk associated with study participation, study drug administration, or interpretation of stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetic bioequivalence of Sunitinib Malate Capsules 50 mg of Oncogen Pharma (Malaysia) Sdn. Bhd. with ‘SUTENT®’ (Sunitinib Malate) Capsules 50 mg of Pfizer Labs in subjects with gastrointestinal stromal tumor or advanced renal cell carcinoma under fasting conditions.Timepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of investigational products.Timepoint: For the subjects who required stabilization period: 105 days For the subjects who do not require the stabilization period: 63 days | — |
Countries
India
Contacts
Public ContactMr Deepak Chawla
Cliantha Research Limited
Outcome results
None listed