A Phase 2a, Multi-center, Placebo-Controlled, Randomized, Assessor-blind Study to Assess the Safety & Efficacy of Parenteral TK-90 or Parenteral TK-90 Placebo to Patients Receiving Radiotherapy for Non-Metastatic Squamous Cell Carcinoma of Head and Neck.
Unknown Phase 2 NCT05658016
Study Description
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.
Study Details
- Registry ID:
- NCT05658016
- Conditions:
- Mucositis
- Phase:
- Phase 2
- Target Enrollment:
- 24 participants
- Start Date:
- Healthy Volunteers:
- No
Study Locations (5 sites)
-
Sher-I-Kashmir Institute of Medical Sciences
Srinagar, Jammu & Kashmir, India -
Bangalore Medical college and Research Institute
Bangalore, India -
Saveetha Medical College and Hospita
Chennai, India -
Apex Hospital
Varanasi, India -
Netaji Subhash Chandra Bose Hospital
Kolkata, India
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