A study to evaluate the safety and effectiveness of BIOMAB in combination with standard treatments like radio-therapy and drug called Temozolamide in patients with brain tumor

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004076

Enrollment

Registered

2013-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Glioblastoma Multiforme

Interventions

Intervention1: Concomitant and Maintenance Stage : Concomitant Stage: Induction BIOMAb-EGFRTM (Nimotuzumab) + RT + TMZ Adjuvant Stage Maintenance BIOMAb-EGFRTM (Nimotuzumab) + adjuvant Maintenance

Eligibility

Inclusion criteria

Inclusion criteria: •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 •LFT •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

Exclusion criteria

Exclusion criteria: •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

Design outcomes

Primary

Measure	Time frame
Overall SurvivalTimepoint: Visit 2 (Day 1) to Visit 105(Day 1852)	—

Secondary

Measure	Time frame
1 Progression free survival 2 Tumor Response 3 Safety & TolerabilityTimepoint: Visit 2 (Day 1) to Visit 105 (Day 1852) Visit 11 (Day 68-70), Visit 25 (Day 225-227), Visit 34 (Day 396), Visit 42 (Day 564), Visit 50 (Day 725), Visit 51 to Visit 104 (Every 3 months) Visit 105 (Day 1852) Visit 2 (Day 1) to Visit 105 (Day 1852)	—

Countries

India

Contacts

Public ContactDr Kiran M Haridas

Biocon Ltd

kiran.haridas@biocon.com08028081234

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026