A clinical trial in Steady state Bioequivalence Study of Sunitinib Malate Capsules 50 mg with Sutent capsules 50 mg in adult patients with advanced renal cell carcinoma already receiving stable dose of Sunitinib Malate Capsules 50 mg under fasting conditions
- Conditions
- Malignant neoplasm of unspecifiedkidney, except renal pelvis,
- Registration Number
- CTRI/2021/03/031750
- Lead Sponsor
- Eugia Pharma Specialities Limited
- Brief Summary
Patients meeting all inclusion and none of the exclusion criteria will be randomized on Day 0. Patients will be randomized to either Test or Reference product of Sunitinib Malate Capsules 50 mg once daily from Day 1 to Day 14 and alternate study treatment as per randomization on Day 15 to Day 28 without washout period. On Day 1, patients will be provided with a diary card to enter the details of study drug consumption at his/ her home On Day 1, patients will be administered one capsule of investigational medicinal product as per randomization schedule at the clinic with 240 mL of drinking water at room temperature. Dosing time on day 1 will be recorded on patient diary and patients will be instructed to follow the same dosing time each day and dosing time will be recorded on the study diary. On Day 1, patients will be provided with sufficient quantity of Investigational medicinal products for dosing at his/ her home from day 2 to day 7. Patient will be requested to come to the clinical facility on day 6 (± 1 day). On Day 6 (± 1 day), patient will be provided with sufficient quantity of Investigational medicinal products for dosing at home from next day to day 11 and patients diary card will be checked for dosing compliance and any adverse event and then the diary card will be handed over to patient again. On Day 11 patients will be required to visit the clinical facility for housing in the subsequent days. Patients shall fast overnight for at least 10.00 hours prior to dosing and should fast for 4.00 hours post dose on Day 14. Water will not be allowed for 1.00-hour pre dose and 1.00-hour post dose on Day 14. During their stay in the clinical facility on Day 12, 13 & 14, subject will be administered the investigational drug at the scheduled time of dosing. Venous blood samples (~4 mL) will be withdrawn within 5 minutes prior to dosing on Day 1, 12, 13 and 14. The pre-dose blood samples will be collected on Day 12, 13 and 14 in Period-I to confirm achievement of steady-state. Pre dose blood sample on day 1 is collected to confirm that patients are on stable dose of Sunitinib capsules. Day 14: On the day of complete pharmacokinetic sampling the post dose venous blood samples (~4 mL) will be withdrawn at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 14.00, 16.00, 20.00 and 24.00 hours post dose administration. All post dose samples will be collected within ± 2 minutes of scheduled time till 9.00 hrs post dose and from 10.00 hrs to 20.00 hrs post dose ± 10 minutes will be allowed. Last sample (i.e. 24.00 hours post dose) on day 15 will be collected within 10 minutes prior to schedule time. Patients will be crossed over to other investigational product (allocated as per randomization schedule) on Day 15, after the last PK sample collection in period-I. Patients will take their first dose of period II on Day 15 at the clinic with 240 mL of drinking water at room temperature at the same time as they take their medications during period I and will be subsequently discharged after they are provided with sufficient quantity of Investigational medicinal products for dosing at his/her home from day 16 to day 21. Dosing time on day 15 will be recorded on patient diary and patients will be instructed to follow the same dosing time (a time window of ± 30 minutes is allowed) each day and dosing time will be recorded on the study diary. Patient will be requested to come to the clinical facility on day 20 (± 1 day) and will be provided with sufficient quantity of Investigational medicinal products for dosing at home from next day to day 25 and patients diary card will be checked for dosing compliance and any adverse event and then the diary card handed over to patient again. On day 25, patients will be required to visit the clinical facility for housing in the subsequent days. During their stay in the clinical facility on Day 26, 27 & 28, patients will be administered the investigational drug at the scheduled time of dosing. Patients shall fast overnight for at least 10.00 hours prior to dosing and should fast for 4.00 hours post dose on Day 28. Water will not be allowed for 1.00-hour pre dose and 1.00-hour post dose on Day 28. Pre-dose blood sample (~4 mL) will be collected within 5 minutes before dosing on Day 26, 27 and 28 to confirm steady state. Day 28 :On the day of complete pharmacokinetic sampling the post dose venous blood samples (~4 mL) will be withdrawn at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 14.00, 16.00, 20.00 and 24.00 hours post dose administration. End of Study assessments will be performed after the last sample is collected on day 29 in Period II and then patient will be discharged from the clinical facility.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
- Male and or female patient of age in between 18 years to 65 years (both inclusive) Patient with confirmed diagnosis of advanced renal cell carcinoma (histological or radiological) Patient who are already receiving a stable dose of Sunitinib Malate Capsules 50 mg once daily as per investigators discretion for at least 14 days at screening Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 2 Patient with estimated life expectancy greater than equal to 3 months Patient should have no clinically significant abnormality in any of the laboratory parameters including ECG and Chest X ray as per the discretion of Principal Investigator at screening only Patient with no persistent toxicities from prior medications Recovery to baseline or lesser tha equal to Grade 1 CTCAE v 5 0 or higher and or stable on supportive therapy at screening visit if any toxicities had occurred unless the toxicities were clinically insignificant Patient with adequate organ and bone marrow function based upon the following laboratory criteria at the time of screening Hemoglobin greater than equal to 9 g per dL Absolute neutrophil count greater than equal to 1500 per uL Platelet count greater than equal to 100000 per uL Creatinine lesser than 2 x ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) lesser than 2.5 x upper limit of normal Total bilirubin within lesser than equal to 1.5 x upper limit of normal Clinically insignificant fasting serum glucose levels, S.
- blood urea nitrogen (BUN) and Urine protein levels Patient and/or Legally Acceptable Representative had given consent after being advised of the nature and risks of the study Female patient of childbearing potential must have a negative serum pregnancy test at screening Females must use acceptable and effective methods of contraception during the study conduct and up to 8 weeks after last does of study drug such as the following: Tubal sterilization (tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1) Intrauterine Device (IUD) Progestin Implant (i e Implanon or its equivalent) Progestin injection or progestin oral contraceptive pill and one barrier method (cervical cap diaphragm, contraceptive sponge or vaginal spermicide and a male or female condom) Two barrier methods used together (cervical cap, diaphragm contraceptive sponge, or vaginal spermicide and a male or female condom) Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner) during the study conduct Male patient must agree to use an effective method of contraception from screening during study and up to 8 weeks after the last dose of study drug Patient willing to and able to comply with the protocol.
Patient who are hypersensitive to Sunitinib and its excipients Patient with hypertension (BP greater than equal to 150 per 100 mm of Hg even after use of more than 1 antihypertensive medication) and cardiac risk factors (e g known congestive heart failure low left ventricular ejection fraction or prolonged QT interval) Patient with hepatic or renal dysfunction as per Investigators Discretion Patient with diagnosis of any second 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 Patient with history of or known brain metastases, spinal cord compression, or carcinomatous meningitis or past history of brain or leptomeningeal disease Patient with history of pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication Patient with major surgery or radiation therapy lesser than 4 weeks of starting the study treatment Patient with severe acute or chronic medical psychiatric condition that could have increased the risk associated with study participation study drug administration or interpretation of study results in the judgment of the investigator Patient who require invasive dental procedures Patient with uncontrolled diabetes as per investigators discretion Patient with history of arterial thrombosis or deep vein thrombosis within the past 12 months Patient within the 6 months prior to study drug administration severe unstable angina symptomatic congestive heart failure or cerebrovascular accident Patient with ongoing cardiac dysrhythmias: atrial fibrillation of any grade or QTc interval prolongation to lesser than 500 msec for males or lesser than 470 msec for females Patient with positive test for hepatitis B surface antigen hepatitis C antibody or human immunodeficiency virus (HIV) 1 and 2 serological test at screening or has been previously treated for hepatitis B hepatitis C or HIV infection Patient with positive test for urine drugs of abuse and or alcohol breath test Patient with history of noncompliance to medical regimens Patient with history of alcoholism alcohol abuse Patient with history of difficulty with donating blood or difficulty in accessibility of veins Patient for whom oral administration of drug is not possible Patient with an unusual or abnormal diet for whatever reason within 48 hours prior to check in e g religious fasting Consumption of grapefruit mosumbi sweet lime juice within 48 hours prior to study check in and for the entire period of study Patient donated blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study Patient participated in another clinical trial in the last 60 days Pregnant and lactating females.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the plasma concentration time curve over the steady state dosing interval pre-dose blood samples collected on 1, 12, 13 and 14 in | Period I and on Day 26, 27 and 28 in Period II. Post dose | samples 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 hours post | morning dose on Day 14 and Day 28 Maximum plasma concentration over the steady state dosing interval pre-dose blood samples collected on 1, 12, 13 and 14 in | Period I and on Day 26, 27 and 28 in Period II. Post dose | samples 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20 and 24 hours post | morning dose on Day 14 and Day 28
- Secondary Outcome Measures
Name Time Method Minimum plasma concentration over the steady state dosing interval. Average plasma concentration over the steady state dosing interval.
Trial Locations
- Locations (37)
Aayush Hospital
🇮🇳Mumbai, MAHARASHTRA, India
American Oncology Institute
🇮🇳Hyderabad, TELANGANA, India
Asian Cancer Hospital
🇮🇳Jaipur, RAJASTHAN, India
Balco Medical Centre
🇮🇳Chandigarh, CHANDIGARH, India
Bhaktivedanta Hospital & Research Institute
🇮🇳Thane, MAHARASHTRA, India
Cancer Clinic and Nursing Home
🇮🇳Nagpur, MAHARASHTRA, India
CIMETS Inamdar Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
GSL Medical College & Hospital
🇮🇳Godavari, ANDHRA PRADESH, India
Harshamitra Oncology Hospital
🇮🇳Tiruchirappalli, TAMIL NADU, India
HCG Cancer Centre
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Scroll for more (27 remaining)Aayush Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Suhas AagrePrincipal investigator9638179565Suhas.aagre@gmail.com