Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Lomustine: 40mg capsules,Subjects will be dosed 130mg/m2 BSA, 1 cycle
Control Intervention1: Gleostine (Lomustine): 40mg capsules Subjects will be dosed 130mg/m2 BSA, 1 cycle
Sponsors
Carnegie Pharmaceuticals
Azidus Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male patients and/or non-pregnant, non-lactating female subjects of child bearing potential and female patients who have attained menopause Patients of age 18 years and above with BMI of 18.50 â?? 29.99 and weight more than 50 Kg. Patients who are diagnosed with brain tumors and have underwent appropriate surgical and-or radiotherapeutic procedures or Hodgkins lymphoma and receiving a stable dose of Lomustine Patients who are prescribed with at least 06 cycles of treatment on Lomustine and completed at least 01 cycle of treatment and have at least 02 cycles of treatment left before initiating the study Patients whose life expectancy of greater than or equal to 3 months. Patients with normal vital parameters, pulse rate and temperature and general clinical examination or those considered not clinically significant as decided by the investigator Patients with no more than one line of chemotherapy Patients with no current or recent treatment with another investigational drug Patients with absence of any major cardiovascular disorder, including but not limited to: myocardial infarction, unstable angina within 6 months prior to randomization, New York Heart Association Grade II or greater congestive heart failure and arrhythmias Patients with biochemical parameters including liver and kidney function as follows Serum creatinine lesser than 2.0 times of upper normal limit AST or ALT lesser than 2.5 times of upper normal limit Alkaline phosphatase lesser than 1.5 times of upper normal limit Normal or clinically insignificant ECG and chest X-ray. Patients with normal or clinically insignificant pulmonary function tests as evaluated by the investigator with predictive forced vital capacity greater than 70 percent. Negative pregnancy test for females and does not plan to become pregnant during course of the study and for 3.5 months after completion of study. Patients who are willing to use one of the following acceptable methods of contraception during the study period and for at least 3.5 months after completion of study Documented tubal sterilization Intrauterine device (IUD) placed 7 days prior to Day 0 Hormonal method started at least 7 days prior to Day 0 plus one barrier method Two barrier methods used together Absolute sexual abstinence Patients or legally acceptable representative who can give written informed consent and communicate effectively.
Exclusion criteria
Exclusion criteria: History of uncontrolled systemic diseases such as cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders, based on clinical investigatorâ??s judgment. History of chronic alcoholism/ chronic smoking/ drug of abuse. Patients with hypersensitivity to Lomustine or any of the excipients. Pregnant or lactating female patient History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing Patients who are positive for hepatitis B, anti-hepatitis C and human immunodeficiency virus (HIV 1&2). Patients with known history of myelosuppression Patients with known history of Pulmonary toxicity Patients with known history of Nephrotoxicity Present or past history of intake of drugs or any prescription drug other than the drugs already included in patientâ??s treatment regimen or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Lomustine or any other medication judged to be clinically significant by the investigator. History of consumption of grapefruit and/or its products within 10 days prior to the start of study. Patients who had not donated blood/had any other blood loss over 01 unit of blood during the last 03 months before study initiation. History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator. Patients who are dysphagic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate bioequivalence between test and reference products.Timepoint: 00.00 (Pre-dose), 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 02.75, 03.00, 03.25, 03.50, 03.75, 04.00, 04.50, 05.00, 06.00, 08.00 and 12.00 h pose dose | — |
Secondary
| Measure | Time frame |
|---|---|
| to monitor the adverse events (AEs) and to assess the safety and tolerability in study subjectsTimepoint: screening & End of the study | — |
Countries
India
Contacts
Public ContactPremnath Loganathan
Azidus Laboratories Ltd
Outcome results
None listed