Comparision of two Temozolomide 250 mg capsules in the patients with Glioblastoma Multiforme or Anaplastic Astrocytoma under fasting condition.

Completed

• Conditions: Malignant neoplasm of brain, unspecified,

• Registration Number: CTRI/2012/09/002951
• Lead Sponsor: Fresenius Kabi Oncology Ltd

Brief Summary

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|Temozolomide is an imidazotetrazine-alkylating agent with antitumor activity. At physiological pH the drug get metabolized to monomethyl triazeno imidazole carboxamide (MTIC). MTIC shows cytotoxicity due to alkylation at the O6 position of guanine with additional alkylation also occurring at the N7 position.

This study is being conducted to compare & characterize the relative bioavailability & pharmacokinetic profile of the Sponsor’s formulation (Temozolomide capsule 250 mg) with respect to the reference formulation (Temodal® (Temozolomide) capsules 250 mg) in single oral dose to adult patients with Glioblastoma Multiforme or Anaplastic Astrocytoma under fasting condition,who in the opinion of their treating physicians are candidates for the Temozolomide therapy.

Temozolomide is a cytotoxic drug; hence the study cannot be conducted on the healthy volunteer.

The primary objective of the study is to characterize the pharmacokinetic profile of the sponsor’s test formulation to that of reference formulation & secondary objective is to monitor the safety of the patients.

Bioequivalence will be concluded if the 90% confidence intervals for ln-transformed pharmacokinetic parameters Cmax and AUC0-t fall within the acceptance range of 0.8 – 1.25 for Temozolomide.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Signed written informed consent for participation in the trial.
• Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.3. Having a Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2.
• Patients with a life expectancy of at least three months.
• Patient with adequate bone marrow, renal and hepatic function.
• Able to comply with study requirement in opinion of Principal Investigator.

Exclusion Criteria

• 1.Known hypersensitivity to Temozolomide, Dacarbazine or any other ingredients of the formulation 2.Use of any chemotherapy drugs within 21 days prior to dosing 3.History of drug/alcohol addiction 4.History of smoking or tobacco chewing in last 3 months 5.Known Galactose intolerant, known deficiency of the Lapp lactase or glucose-galactose malabsorption 6.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies or positive VDRL test 7.Patients with HIV infection.
• 8.Positive for Drug of abuse test and alcohol screen test 9.Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic profile of the sponsor’s test formulation (Temozolomide 250 mg capsules) relative to that of reference formulation	The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25 | (15 min), 0.33 (20 min) 0.50 (30 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50,3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each period | administration.
(TEMODAL® 250 mg capsules) in adult, male or female, patients under fasting conditions and to assess the bioequivalence	The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25 | (15 min), 0.33 (20 min) 0.50 (30 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50,3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each period | administration.

Secondary Outcome Measures

Name	Time	Method
To monitor the safety of the patients exposed to the Investigational Medicinal Product	NIL

Trial Locations

Locations (13)

Acharya Harihar Regional Cancer Centre; 🇮🇳 Cuttack, ORISSA, India

Axon Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Belgaum Cancer Hospital; 🇮🇳 Belgaum, KARNATAKA, India

BIBI General Hospital & Cancer Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

CHL-Apollo Hospitals; 🇮🇳 Indore, MADHYA PRADESH, India

City cancer centre; 🇮🇳 Krishna, ANDHRA PRADESH, India

Deenanath Mangeshkar Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Green City Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Lions Cancer Detection Centre; 🇮🇳 Surat, GUJARAT, India

M.S.Ramaiah medical college and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

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Acharya Harihar Regional Cancer Centre

🇮🇳Cuttack, ORISSA, India

Dr Senapati

Principal investigator

9437031718

snsenapati2007@gmail.com