An Open Label, Prospective, Multicentric Study to Evaluate the Safety and Efficacy of BIOMAb-EGFRTM (Nimotuzumab) As Induction and Maintenance Therapy in Combination with Radiotherapy plus Temozolomide (Concomitant and Adjuvant) In Indian Patients with Glioblastoma Multiforme

Biocon limited0 个研究点目标入组 56 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Willingness by the Patient or Legally acceptable representative (LAR) to sign the informed consent
•Newly diagnosed patients with GBM (Grade 4 Astrocytoma) confirmed by histopathology
•Patients suitable for planned radiotherapy and chemotherapy with TMZ
•Patients who are chemotherapy naive
•Patients aged between 18 - 70 years (both inclusive)
•Karnofskyâ??s Performance Status >= 60%
•Adequate hematological, renal & hepatic function defined as:
•Hb ï?³ 9g/dL, ANC ï?³ 1500/mm3 & Platelet count ï?³ 100,000 /mm3
•Serum creatinine <= 1.5 times ULN for laboratory
•LFT < 3 times ULN for laboratory
•Patients who have undergone debulking surgery or tumor biopsy in the last 4 weeks are eligible for enrollment
•Patients should be willing to use effective methods of contraception during the study

•Female patients who are pregnant or breast feeding
•Patients with severe underlying disease or not controlled by treatment in the opinion of the principal investigator
•HIV, Chronic Hepatitis B or C if found to be positive
•Hypersensitivity to TMZ and BIOMAb-EGFRTM (Nimotuzumab) or any of its components
•Previous or concurrent malignancies in other sites except surgically cured carcinoma-in-situ of cervix & non melanoma skin cancer

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