Bioavailability study of Sunitinib Capsules 50mg of with SUTENT® (Sunitinib Malate) Capsules 50mg in adult human patients with Gastrointestinal Stromal Tumors (GIST) or Advanced Renal Cell Carcinoma (RCC) under fed conditions
- Conditions
- Health Condition 1: C491- Malignant neoplasm of connective and soft tissue of upper limb, including shoulder
- Registration Number
- CTRI/2021/04/033234
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able to provide voluntary informed consent prior to any study-related activities being performed and to follow protocol requirements.
2. Male or Female patients aged 18 to 65 years (both inclusive) having body mass index at least 17.00 calculated as weight in kg per height in m2
3. Patients with histologically or cytologically confirmed renal cell carcinoma which is in advanced stage.
OR
Patients with histologically or cytologically confirmed gastrointestinal stromal tumor, after disease progression or intolerance to imatinib mesylate
4. Patients for whom sunitinib is indicated and who are already receiving a stable dose of sunitinib malate capsules.
5. Patients who are able to swallow and retain oral medication.
6. Eastern Cooperative Oncology Group performance status less than or equal to 2
7. Acceptable hematology status:
a. Hemoglobin Greater than or equal to 9 g per dl
b. Absolute neutrophil count Greater than or equal to 1500 cells per microliter
c. Platelet count Greater than or equal to 1, 00,000 cells per microliter
8. Acceptable liver function:
a. Alanine aminotransferase less than or equal to 2.5 X upper limit of normal (In case of liver metastases: less than 5 X ULN)
b. Aspartate aminotransferase (AST) less than or equal to 2.5 X ULN In case of liver metastases: less than 5 X ULN
c. Bilirubin less than or equal to 1.5 X ULN
9. Patients with serum creatinine less than or equal to 1.5 X ULN
10. Patients with life expectancy of at least 6 months at the time of enrolment.
11. Cardiac ejection fraction Greater than or equal to 50 percent by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within 28 days prior to first dose of Investigational product.
12. Female patients with negative serum pregnancy test at screening.
13. Male patients who agree to use effective contraception during treatment and for 7 weeks after the last investigational product dose.
14. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any acceptable methods of contraception during study and for at least 4 weeks after the last investigational product dose.
Acceptable methods of contraception are
a. Oral, parenteral (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 or intrauterine system
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 patient)
e. Female sterilization surgical bilateral oophorectomy or tubal ligation within at least 6 weeks prior to study participation
f. Total abstinence, partial abstinence is not acceptable
15. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
1. Known hypersensitivity or contraindication to Sunitinib malate or similar products or to any of the components of investigational product.
2. Patients on concomitant medication with drugs known to be inhibitors and/or inducers of CYP3A4.
3. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, renal dysfunction, diabetes mellitus, hypertension etc.)
4. History or presence of Thrombotic microangiopathy (TMA), proteinuria or any other dermatological toxicity.
5. Patients who are at risk of tumor lysis syndrome.
6. Male Patients with QTc of > 450 msec and female patients with QTc > 470 msec.
7. Patients with known CNS metastasis.
8. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational product.
9. Surgical or other non-healing wounds.
10. Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or Rapid Plasma Reagin (RPR).
11. Patients with positive urine screen for drugs of abuse.
12. History of other malignancies in the last 5 years including lung cancer (except in situ cancer or basal or squamous cell skin cancer).
13. 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) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V 5.0).
14. Participation in any clinical study within 90 days prior to receiving the first dose of Investigational product.
15. Donation of blood greater than or equal to 350 ml within 90 days prior to receiving the first dose of investigational product for the current study.
16. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
17. Any other condition(s) which could significantly interfere with protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.
18. Pregnant or lactating women.
19. Patient with positive coronavirus infection (COVID-19).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method