Clinical trial to compare two drugs, Temodal and Temozolomide 250 mg capsules in cancer patients

Recruiting

• Conditions: Glioblastoma Multiforme or Anaplastic Astrocytoma

• Registration Number: CTRI/2011/12/002274
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

It is a multicentre, randomized, open-label, single dose, two-treatment, two period, two sequence, crossover, pivotal bioequivalence study of Test Temozolomide 250 mg capsule manufactured by Reliance Life Sciences Pvt. Ltd., India with Reference Temodal 250 mg capsule of Schering- Plough Ltd, UK in adult, male and/or female cancer patients under fasting conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-15
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male or female 18 to 70 years of age.
• Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
• Cancer patients (glioblastoma multiforme or anaplastic astrocytoma) who are already receiving or are about to start receiving temozolomide 250 mg once daily as their calculated individualized dose (e.g. based upon factors such as tumor type, body surface area, cycle number and toxicity).
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Patients with Karnofsky Performance Status of at least 70%.
• Patients with life expectancy of atleast 3 months.
• Patients should be non-smokers.
• Patients willing to voluntarily provide written informed consent or consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent.

Exclusion Criteria

• Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
• Pregnant (female subjects with a positive serum pregnancy test at screening and positive urine pregnancy test before check-in in period I) or lactating females.
• Patients with abnormal laboratory parameters like: a.
• Serum creatinine greater than 2.0 times of upper normal limit b.
• AST or ALT greater than 2.5 times of upper normal limit c.
• Alkaline phosphatase ≥1.5 times of upper normal limit d.
• Platelet count less than 100,000/μL.
• Hemoglobin less than 8.0 g/dL.
• Total WBC Count less than 4000 /µL g.
• ANC value less than 1500 /µL Seizure symptoms, which significantly interfere with normal life and restrict medical treatments that are necessary for patient care.
• Patients with chemotherapy or biologic anticancer therapy within 4 weeks before study or nitrosourea therapy within 6 weeks before study entry.
• Patients planned or currently receiving focal radiotherapy.
• Patients with a known history of drug hypersensitivity to temozolomide or any of the excipients of the formulations.
• Patients with known history of galactose intolerance or glucose-galactose malabsorption.
• History or evidence of cardiac disease (Myocardial Infarction in last 6 months, unstable angina, heart failure, uncontrolled ventricular arrhythmia, significant pericardial disease).
• Patients with a history of alcohol, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except required as medication for current medical condition.
• Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
• Patients receiving sodium valproate Patients who participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months.
• History or evidence of clinically significant systemic disease or any other condition which investigator feels would pose a significant hazard to patients if IP is administered.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters:	• Cmax: Day 1, Day 2 | • AUC0--t: Day 1, Day 2
• Cmax	• Cmax: Day 1, Day 2 | • AUC0--t: Day 1, Day 2
• AUC0--t	• Cmax: Day 1, Day 2 | • AUC0--t: Day 1, Day 2

Secondary Outcome Measures

Name	Time	Method
1. To monitor all the adverse events, including laboratory parameters	2. To determine other pharmacokinetic parameters of Test and Reference products.

Trial Locations

Locations (12)

Cancer Clinic 208; 🇮🇳 Nagpur, MAHARASHTRA, India

Curie Manavata Cancer Centre,; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. Baraskar Hospital and Cancer Care Center; 🇮🇳 Nagpur, MAHARASHTRA, India

Kamakshi Memorial Hospital; 🇮🇳 Chennai, TAMIL NADU, India

M.S. Ramaiah Memorial Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Medipoint Hospitals Pvt. Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Meenakshi mission hospital; 🇮🇳 Chennai, TAMIL NADU, India

Narayana Hrudayalaya Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Shatabdi Super Specialty Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

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Cancer Clinic 208

🇮🇳Nagpur, MAHARASHTRA, India

Dr Smita Gupte

Principal investigator

9373107176

smita_gupte@rediffmail.com