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 Reliance LIfe Sciences Pvt Ltd
- Conditions
- Health Condition 1: C49A- Gastrointestinal stromal tumorHealth Condition 2: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2020/12/029491
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult patients suffering from advanced renal cell carcinoma or gastrointestinal stromal
tumour
2. Patients with confirmed diagnosis of advanced renal cell carcinoma or gastrointestinal stromal tumour already receiving a stable once-daily dose of Sunitinib 50 mg for at least 2 weeks.
3.Patient has adequate organ function, defined as following:
- Hemoglobin �9.0 g/dL
- Absolute neutrophil count (ANC) � 1500 cells/mm3
- Platelet count � 100,000/ mm3
- Total bilirubin �1.5 x Upper Limit of Normal (ULN)
- Serum SGPT / SGOT � 2.5 x ULN
- Serum albumin �2 g/dL
- Serum Creatinine < 1.5 x ULN
4. Patients willing to voluntarily provide written informed consent.
5.Males with female partners of reproductive potential must be willing to use a male condom
during sexual intercourse during the study period and for ten weeks after the last dose of study medication.
6.Patients willing to undergo pre and post-study physical examinations and laboratory
investigations.
7. Eastern Cooperative Oncology Group performance status of <2.
8.Patients willing to adhere to protocol and they should not consume coffee, tea, chocolate,
grape fruit juice or soft drink at least 24 hours prior to investigational product administration and during their clinical stay in each study period.
9.Patient should be willing to adhere to the protocol and they should not consume alcohol at
least 48 hours prior to dosing and should agree not to take any amount of alcohol during the
study period.
10. Patients able and willing to comply with the protocol requirements.
1. Patients incapable of understanding the informed consent process.
2. Patients with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study
3. Patients with evidence of psychiatric disorder likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
4. Patients with any evidence of clinically significant organ dysfunction or any clinically
significant deviation from normal in their physical or clinical evaluation including ECG, 2D, Echocardiography and X-ray results.
5. Any treatment which could affect the pharmacokinetic of Sunitinib /known
interactions
6. Patients with a known history of drug hypersensitivity to Sunitinib or any excipients of the formulation.
7. History of difficulty in swallowing, or any gastrointestinal disease e.g. ulcerative colitis, ulcerative stomatitis, malabsorption syndrome and/or lack of physical integrity of the upper intestinal tract which could affect drug absorption
8. Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and with history of drug abuse, found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates).
9. Patients who are diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV)
virus reactive/positive.
10.Patients with clinically significant abnormal haemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count and hematocrit
11. Patients who, have clinically significant abnormal laboratory values for serum creatinine,
blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine
aminotransferase (ALT), serum alkaline phosphatase (ALP), serum bilirubin, serum glucose (fasting) , thyroid function tests and serum electrolytes.
12. Patients with a clinically significant past history or current medical condition of:
ïâ??· Pulmonary disorders (COPD and asthma)
Cardiovascular disorders QTc interval >450 msec for males or >470 msec for
females, uncontrolled hypertension), abnormal 2 D ECHO with LVEF <45%
ïâ??· Neurological disorders (especially seizures, migraine)
ïâ??· Hepatic disorders
ïâ??· Abnormal thyroid function
ïâ??· Grade ââ?°Â¥3 hemorrhage within 4 weeks prior to first IP dosing
ïâ??· Thrombotic micro-angiopathy (TMA), including thrombotic thrombocytopenic
purpura and hemolytic uremic syndrome
13. Females of childbearing and reproductive potential not willing to follow following
requirement.
ïâ??· Females of childbearing potential ready to undergo serum pregnancy test at screening
and urine pregnancy test at subsequent visit as per protocol requirement and
investigators assessment
ïâ??· Females of childbearing and reproductive potential must be willing to use adequate
contraception (as defined below) at least four weeks before the first dose of the study
drug except as noted and continuing at least four weeks after the last dose of the study
drug. For this study, acceptable and effective methods of contraception for females
include-
ïÆ?Ë?Intrauterine device placed at
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