Bioequivalence (BE) Study of Pazopanib in subjects with Advanced renal cell carcinoma.
- Conditions
- Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2020/11/029079
- Lead Sponsor
- Alvogen PB RD LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able to provide voluntary informed consent and to follow the protocol requirements.
2. Subjects aged 18 to75 years (both inclusive) having Body Mass Index (BMI) at least 17.00 calculated where weight in kg and height in m2.
3. 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 HCl tablets of 800 mg per day for at least 4 weeks OR (c) Subjects with failure of first line treatment for advanced renal cell carcinoma and as per investigatorââ?¬•s discretion are eligible to receive Pazopanib HCl tablets.
4. Subject is able to swallow and retain oral medication.
5. Life expectancy of at least 3 months at the time of enrolment.
6. 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 1,00,000 cells per mm3
7. Acceptable liver function:
a. Alanine aminotransferase ALT less than or equal to 2 X ULN
b. Aspartate aminotransferase AST less than or equal to 2X ULN
c. Bilirubin less than or equal to ULN
d. Alkaline phosphatase less than or equal to 5 X ULN
8. Subjects with Creatinine clearance greater than or equal to 30 mL per minute
9. Cardiac ejection fraction greater than or equal to 50 percent by echocardiogram ECHO within 28 days of first dose of Investigational Product.
10. Male subjects including those who had a vasectomy with female partners of reproductive potential must agree to use condom from screening, during study and for at least two weeks after treatment discontinuation.
11. Female subjects with negative serum pregnancy test at screening and at the time of randomization.
12. 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 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 IUD or intrauterine system IUD or IUS
c. Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent
d. Male sterilization at least 6 months prior to the screening, should be the sole male partner for that subject
e. Female sterilization surgical bilateral oophorectomy or tubal ligation at least 6 weeks prior to study participation
f. Total abstinence, partial abstinence is not acceptable.
13. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
. 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 history of cardiac disease at the time of screening
4. Subject found with major vascular disease 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 and CYP450 inducer or inhibitor; narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2D6 or CYP2C8; simvastatin, H2 receptor antagonist and PPIs.
6. If a subject is on anti-coagulant therapy during study participation.
7. Receiving any drugs known to prolong the QT interval within 4 weeks prior to study or during the study.
8. Known CNS metastasis.
9. History or presence of Thrombotic microangiopathy (TMA) or any other dermatological toxicity.
10. A subject with ECOG Performance Status of > 2.
11. Major surgical procedure (including periodontal) within 28 days of study participation.
12. Surgical or other non-healing wounds.
13. A subject with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
14. A subject testing positive for Coronavirus infection (COVID-19).
15. A subject with current clinical or laboratory evidence of active infection.
16. History of other malignancies in the last 5 years.
17. Has 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).
18. Subject is positive in alcohol breath test.
19. Subject is positive in urine screen for drug abuse.
20. Participation in any clinical study within 90 days before enrollment in the study.
21. Loss of greater than or equal to 350mL (1 unit) of blood within 90 days before enrollment in the study.
22. 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. 23. Lactating women.
24. History of difficulty in accessibility of veins or intolerance to venipuncture.
25. Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator could contraindicate the subjectââ?¬•s participation in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method