Study of Sunitinib malate Capsules 50mg among cancer patients under treatment with stable dose of Sunitinib malate capsules conducted at multiple centers in India where patients will be treated with Sutent 50mg (as Reference) and Sunitinib 50mg by MSN company

Not Applicable

Recruiting

Conditions: Health Condition 1: C159- Malignant neoplasm of esophagus, unspecifiedHealth Condition 2: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis

Registration Number: CTRI/2019/07/020203

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

Inclusion Criteria

A patient fulfilling all the following criteria will be included in the present study:

Patients:

1) Willing to provide written informed consent for participation in the study.

2) Having ability to comprehend the nature and purpose of the study.

3) Willing to be available for the entire study period and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including anticipated ability to swallow capsules, as per study protocol.

4) Disease population:

a) Patients with documented clinical diagnosis of GIST after disease progression on or intolerance to Imatinib mesylate;

b) Patients with documented clinical diagnosis of advanced RCC.

5) Treatment condition: Patients under treatment of stable daily dose of Sunitinib malate capsules 50mg.

6) Patients for whom a titration away from the stabilized once daily dose of 50mg of Sunitinib is unlikely for a study duration.

7) Age of 18-65 years (both inclusive).

8) Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 â?? 2 (both inclusive).

9) Patients with life expectancy of at least 3 months.

10) Adequate organ function, defined as following:

a) Hemoglobin >=9.0 g/dL

b) Absolute neutrophil count (ANC) >= 1500 cells/mm3

c) Platelet count >= 100,000/ mm3

d) Total bilirubin <=1.5 x Upper Limit of Normal (ULN)

e) SGPT / SGOT <= 2.5 x ULN

f) Serum albumin >=2 g/dL

g) Serum Creatinine < 1.5 x ULN

h) Urine protein < 3gm/24 hr urine sample in case if urinalysis shows 2+ protein (in dip-stick method).

11) With a normal or clinically non-significant laboratory values (apart from those mentioned above) as determined by hematological, biochemistry tests and urine analysis.

12) With a normal or clinically non-significant 12-lead ECG.

13) With a normal or clinically non-significant 2D Echo (performed within 3 months of screening).

14) Non-smokers or ex-smoker or mild / moderate smokers and willing to abstain from chewing or smoking any tobacco containing product at least 72.00 hrs prior to first dosing of the study and throughout study.

15) Willing to abstain from alcohol or alcoholic products within 24.00 hrs prior to first dosing of the study and throughout the study.

16) Willing to abstain from, xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 72.00 hrs prior to first sample collection and throughout sampling points during each study period.

17) Willing to abstain from grapefruit or its juice within 72.00 hrs prior to first dosing of the study and throughout the study.

18) In case of male patients:

a) Patients either abstain from sexual intercourse or who are willing to use adequate contraception (e.g. Use of condoms) during sexual intercourse with female partners of child bearing potential 7 weeks prior to first dose in the study till 7 weeks post last dose of the study.

19) In case of female patients:

a) Negative urine pregnancy test during screening and, negative serum Î²-HCG test at baseline, enrolment & randomization visit and during check-in for housing during each

Exclusion Criteria

A patient fulfilling any one of the following criteria will be excluded from the study:

1) Institutionalized patients;

2) A history of allergic or hypersensitive reactions to Sunitinib malate or related group of drugs or to any of the excipients of formulation which in the opinion of an investigator, would compromise the safety of the patient or the study;

3) History of another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention;

4) Significant history or current evidence of chronic â?? infections, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction, which in the opinion of an investigator, would compromise the safety of the patient or the study;

5) Any of the following features within 3 months of the administration of Sunitinib malate: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, low LVEF (left ventricular ejection fraction), cerebrovascular accident, or transient ischemic attack;

6) Hypertension that cannot be controlled by medications;

7) QTc interval >450 msec for males or >470 msec for females;

8) Ongoing cardiac dysrhythmias of NCI CTCAE v5.0 >=grade 2, atrial fibrillation of any grade;

9) Grade >=3 hemorrhage within 4 weeks prior to first dose of IP;

10) History or currently under significant bleeding disorder and/or receiving concomitant therapy of Warfarin (coumarin anticoagulants) or history of usage of coumarin anticoagulants in the previous three months prior to study start (dosing);

11) Patients who are at clinically high risk of developing tumor lysis syndrome during the study;

12) Previous/current history of hematopoietic stem cell transplantation;

13) History of difficulty in swallowing which could affect drug absorption;

14) A medical or surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of Sunitinib malate during the study;

15) History of or currently present significant hematological disorder (drug-induced or idiopathic);

16) History of or currently present significant liver disease;

17) History or requirement of therapy with CYP3A4 activity inducer or inhibitor drug within 14 days prior to first dosing of the study and till study completion;

18) Concurrent use of drugs known to suppress bone marrow function;

19) Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication;

20) Expected incompliance with outpatient medications;

21) A history of alcohol or drug dependence during the 6-month period immediately prior to first dosing of the study;

22) Positive alcohol breath or urine drug of abuse tests during randomization visit and at check-in procedure of each study period;

23) Positive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HbsAg) or Hepatitis C virus (HCV) antibodies;

24) In case of female patient

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to assess <br/ ><br>whether the test product is bioequivalent to <br/ ><br>reference product after dosing subjects for 28 <br/ ><br>days on 50mg once a day SunitinibTimepoint: 28 Days after Randomization

Secondary Outcome Measures

Name	Time	Method
The secondary objective is assessment of safety <br/ ><br>and tolerability profile of test and reference <br/ ><br>products.Timepoint: 28 Days after Randomization