A study comparing Everolimus tablets 10 mg to the reference drug AFINITOR® 10 mg tablets in patients of Renal cancer
- Conditions
- Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
- Registration Number
- CTRI/2018/11/016322
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients willing to give written informed consent for participation in the trial.
2.Male or female patients must be 18 years and 70 years of age at the screening visit.
3.Patients who are already receiving Everolimus at a dose of 10 mg once a day for at least 16 consecutive days prior to screening.
4.Patients with histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma (RCC) who require Everolimus 10 mg daily.
5.Patients must have an ECOG performance status of 0-2.
6.Patients must have an adequate bone marrow and renal function
7.Patients should be able to comply with study procedures in the opinion of the investigator.
8.In the case of female patients, the serum pregnancy test at the screening visit and the urine pregnancy test at Day 01 (before dosing) must be negative.
9.Patients willing to avoid use of any recreational drugs/tobacco products/alcohol during the study (from screening to end of the study).
10.In the case of female patients: sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must agree to use an effective method [abstinence, hormonal (oral, implant, transdermal, vaginal or injection) except Mifepristone, barrier (condom with spermicide, diaphragm with spermicide), Intra Uterine Device or vasectomized partner (6 months minimum)]of avoiding pregnancy for at least 15 days prior to study drug administration, during study and up to 8 weeks after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
11.In the case of male patients: patients must use an effective method of avoiding pregnancy [Vasectomy (for at least 6 month prior to study), barrier (Condom with spermicide) &abstinence] or partner must use and effective method of contraception [hormonal (oral, implant, transdermal, vaginal or injection) except Mifepristone, barrier (condom with spermicide, diaphragm with spermicide), Intra Uterine Device] for at least 15 days prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
It is the investigatorâ??s responsibility to ensure that the above points regarding an effective method of avoiding pregnancy are discussed with the patient in detail and the patient agrees to this and it is documented in source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol
1.Known hypersensitivity to Everolimus or to other rapamycin derivatives or any of its excipients.
2.Patients with human immunodeficiency virus (HIV) infection.
3.A positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
4.Patients with renal failure and/or hepatic failure
5.Patients for whom the need for dose change during the study can be anticipated.
6.Any prior treatment with everolimus resulting in unacceptable toxicity.
7.Receipt of any type of small molecule kinase inhibitors (i.e. axitinib, pazopanib, sorafenib, sunitinib etc) within 2 weeks before randomization.
8.Known brain metastasis, spinal cord compression, or carcinomatous meningitis.
9.Participation in another clinical trial in the last 60 days.
10.History of noncompliance to medical regimens.
11.Patients for whom oral administration of drug is not possible.
12.Patients with uncontrolled diabetes mellitus.
13.Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
14.Patients with another active cancer other than the disease condition under study.
15.Patients on drugs known to be inducers or inhibitors of CYP3A4 family and on P-glycoprotein (PgP) Inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole etc.) within 1 month of enrollment in the study.
16.Patients that have been immunised with a live vaccine within 1 month of enrollment in the study.
17.Patients with Child-Pugh class A, B and C (mild, moderate and severe hepatic impairment, respectively) hepatic impairment.
18.Use of any recreational drugs or history of drug addiction.
19.Patients with positive urine drug screen and/or breath alcohol analyzer test
(Note: Patients taking opioid/ benzodiazepine at therapeutic dose will not be excluded)
20.Donation of blood (including all components) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
21.Any other condition or abnormal baseline findings that, in the investigatorâ??s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
22.The receipt of an investigational medicinal product within a period of 30 days prior to the first dose of investigational medicinal product for the current study.
23.Patients with a history of difficulty in donating blood or difficulty in accessibility of veins.
24.Female patients who are lactating.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Characterization of the pharmacokinetic profile of the sponsorâ??s test formulation (Everolimus 10 mg tablets) relative to that of the reference formulation AFINITOR® 10 mg tablets (Everolimus 10 mg tablets) in patients of Advanced Renal Cell Carcinoma and assessment of bioequivalence at steady state under fasting conditionsTimepoint: Days 14, 15, 16, 30, 31 and 32
- Secondary Outcome Measures
Name Time Method Safety of the patientsTimepoint: During entire duration of the study