CTRI/2021/06/034245 [Registered on: 15/06/2021] Trial Registered Prospectively
Last Modified On:
26/09/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Compare and evaluate the bioavailability of Sunitinib Malate Capsules 50 mg of Oncogen Pharma (Malaysia) Sdn. Bhd. and ‘SUTENT®’ (Sunitinib Malate) Capsules 50 mg of Pfizer Labs in Subjects with Gastrointestinal Stromal Tumor or Advanced Renal Cell Carcinoma under Fasting Conditions.
Scientific Title of Study
An Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Multiple-Dose, Steady State Multicentre, Bioequivalence Study of Sunitinib Malate Capsules 50 mg of Oncogen Pharma (Malaysia) Sdn. Bhd. and ‘SUTENT®’ (Sunitinib Malate) Capsules 50 mg of Pfizer Labs in Subjects with Gastrointestinal Stromal Tumor or Advanced Renal Cell Carcinoma under Fasting Conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A00507 Version: 02 Date: 26 Mar 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight, Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad
GUJARAT- 380054, India
Ahmadabad GUJARAT 380054 India
Phone
079-66219555
Fax
079-66219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Praveen Chowdhary
Designation
Manager – Clinical Trial Medical Services
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight, Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev Ahmadabad
GUJARAT- 380054, India
Ahmadabad GUJARAT 380054 India
Phone
9879363847
Fax
079-66219549
Email
pchowdhary@cliantha.com
Details of Contact Person Public Query
Name
Mr Deepak Chawla
Designation
Project Manager - Clinical Trials
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight, Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev Ahmadabad
GUJARAT- 380054, India
Ahmadabad GUJARAT 380054 India
Phone
079-66219534
Fax
079-66219549
Email
dchawla@cliantha.com
Source of Monetary or Material Support
Oncogen Pharma (Malaysia) Sdn. Bhd.
Primary Sponsor
Name
Oncogen Pharma Malaysia Sdn Bhd
Address
3, Jalan Jururancang U1/21,
Hicom-glenmarie Industrial Park,
40150 Shah Alam, Selangor, Malaysia
An oral dose (single capsule) of either the test product Sunitinib
Malate Capsules 50 mg or reference product ‘SUTENT®’ (Sunitinib
Malate) Capsules 50 mg will be administered once daily from Day 01
to Day 14 in each period.
Comparator Agent
SUTENT®’ (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 mg will be administered once daily from Day 01
to Day 14 in each period.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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 < 3gm/24 hr urine sample in case if urinalysis shows 2+ protein (in dip-stick method)
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
ExclusionCriteria
Details
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 study result.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
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.
2 weeks
Secondary Outcome
Outcome
TimePoints
To evaluate the safety and tolerability of investigational products.
For the subjects who required stabilization period: 105 days
For the subjects who do not require the stabilization period: 63 days
Target Sample Size
Total Sample Size="46" Sample Size from India="46" Final Enrollment numbers achieved (Total)= "46" Final Enrollment numbers achieved (India)="46"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
An Open-Label, Randomized, Two-Period, Two-Treatment,
Two-Sequence, Crossover, Multiple-Dose, Steady State Multicentre,
Bioequivalence Study of Sunitinib Malate Capsules 50 mg of Oncogen Pharma
(Malaysia) Sdn. Bhd. and ‘SUTENT®’ (Sunitinib Malate) Capsules 50 mg of Pfizer
Labs in Subjects with Gastrointestinal Stromal Tumor or Advanced Renal Cell
Carcinoma under Fasting Conditions.
Objective:
·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.
To evaluate the safety and tolerability of
investigational products.