A Phase 2a, Multi-center, Open Label, Dose Optimization, Pilot Study to Assess the Safety and Tolerability at the Maximum Tolerated Dose of Parenteral TK-112690 in Non-Metastatic Squamous Cell Carcinoma of Head and Neck Patients Scheduled to Receive Chemoradiation. - NIL
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.
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.
A Phase 2a, Multi-centre, Placebo Controlled, Randomized, Assessor Blind Study of Bolus 5-fluorouracil and Infused Leucovorin Plus Either Infused TK-90 for Parenteral Use or Infused TK-90 Placebo Administered Weekly for 6 Consecutive Weeks to Patients With Colorectal Cancer.
Patients expected to receive a 500 mg/m2 of Leucovorin by iv & 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours & 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.
100 项与 TK-112690 相关的专利(医药)