Pharmacokinetic Study of Pazopanib in Advanced Renal Cell Carcinoma patients
- Conditions
- Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2022/04/042340
- Lead Sponsor
- MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients should fulfil all inclusion and none of the Exclusion criteria for enrolment in the study.
1. Male or non-pregnant female patients between 18 - 75 years of age.
2. Patient willing to give written informed consent and comply with treatment and follow up.
3. Patient whose organ and immune system functions are normal or adequate as indicated by the laboratory values or considered by the Investigator/sub-Investigator to be of no clinical significanceâ??.
Hematologic:Absolute neutrophil count (ANC) >= 1.5 X 109/L Platelets >= 100 X 109/L Hemoglobin >= 9.0 g/dL Prothrombin Time (PT) <= 1.2 X ULN International Normalized Ratio (INR) <= 1.2 X ULN activated Partial Thromboplastin Time (aPTT) <= 1.2 X ULN,Hepatic:Total bilirubin <= 1.5 X ULN AST and ALT <= 2.0 X ULN,Renal;Serum creatinine <= 2 mg/dL Creatinine clearance >= 30 mL/min
4. Histopathological or Radiological diagnosis (Only PET Scan) of advanced RCC patient.
5. No significant medical comorbidities or inter current illnesses that could limit compliance with study medications or increase the risk of treatment-related toxicities.
6. Patients with confirmed advanced RCC who are on a stable dose (at least 28 days) of pazopanib tablets 800 mg once daily.
7. Patient, who in the opinion of the Investigator has a life expectancy greater than or equal to 3 months from the time of the first dose.
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2(Appendix 4).
9. No persistent toxicities from prior medications [Recovery to baseline or less than or equal to Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or) higher and/or stable on supportive therapy at screening visit if any toxicities had occurred unless the toxicities were clinically insignificant].
10. Patient with cardiac ejection fraction within the normal range as measured by echocardiogram.
11. The patient must have a clinically acceptable 12-lead ECG at screening including QTc interval <= 480 msec.
12. Patient must have clinically acceptable results for all the screening parameters and investigations.
13. Able to swallow and retain orally administered medication.
14. Availability of patient for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent.
15. Female patient
a) of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.); for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same during treatment and for at least two weeks after the last dose or withdrawal/ discontinuation from the study. The patient agrees to accept the risk that pregnancy could still result despite using birth control devices. OR
b) Postmenopausal for at least the past 12 months. OR
c) Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the patient).
16. Male patient must agree to practice an acceptable method of birth control such as sexual abstinence, a barrier method of contraception (i.e. condom) for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same treatment and for at least two weeks after the last dose treatment
1. Pregnant and lactating female.
2. Patient receiving any medications or substances that are strong inhibitors or inducers of the CYP450 enzyme.
3. Patient having any history or receiving any drugs known to prolong the QT interval within 4 weeks before the study or using Bazettâ??s Formula.
4. Patient with risk factors for prolonged QTc interval and Torsades de Pointes..
5. Patient participated in any study which involves blood loss in the last 90 days and/or donated blood (1 unit or 350 ml) within 90 days prior to dosing in the study and/ or history of difficulty with donating blood.
6. Patient with brain metastases as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).
7. Patient with history of pre-existing thyroid abnormality that cannot be maintained in the normal range with medication.
8. Patient with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease.
- Known intraluminal metastatic lesion/s with the risk of bleeding.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before study treatment.
- Malabsorption syndrome
- Major resection of the stomach or small bowel.
9. Any other significant medical comorbidities or intercurrent illnesses or infection which may have an impact on patient safety and do not permit the dosing of Pazopanib HCl as determined by the Investigator.
10. Patient with uncontrolled hypertension while receiving appropriate medication (systolic blood pressure >= 150 mmHg and diastolic blood pressure > 90 mmHg).
11. Abnormal electrolytes (Sodium, Potassium, Calcium & Magnesium) or patient with long QT syndrome.
12. Presence of proteinuria.
13. History of any one of the following cardiac conditions within the past 6 months;
- Cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class III or IV congestive heart failure as per NYHA, serious cardiac arrhythmias, cerebrovascular accident, stroke (including transient ischemic attack), pulmonary embolism or untreated deep venous thrombosis.
14. Haemoptysis within 6 weeks of screening.
15. Evidence of bleeding diathesis or coagulopathy.
16. Anticoagulant treatment with curative intent.
17. Alcohol dependence, alcohol abuse, or drug abuse, or addiction with any recreational drug within the past year.
18. Patient who have consumed grapefruit, citrus fruits, and its products for 48 hours before first dosing.
19. Patient who have consumed any xanthine-containing items (i.e. tea, coffee, cola drinks, or chocolate/coca, etc.) for 48 hours before first dosing.
20. Allergy or significant history of hypersensitivity or idiosyncratic reactions to study drug product or its excipients etc.
21. History of difficulty in swallowing.
22. Clinically assessed as having inadequate venous access for PK sampling.
23. Patient deemed uncooperative or non-compliant.
24. Patient who have shown positive results in urine alcohol test and/or urine drug screening test.
25. Significant abnormal 12 lead ECG, Chest X-ray, and 2D-Echocardiography finding.
26. A positive result of HIV, HCV, RPR, and
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method