At a glance
ClinicalIndex Comparison Record- ✓Age over 18 years with histologically or cytologically confirmed locally residual, recurrent, or metastatic SCCHN
- ✓Failed at least one course of non-MTX chemotherapy, or one course of non-MTX chemotherapy and chemoradiation
- ✓ECOG performance status 0 to 2
- ✓Life expectancy at least 6 months
- ✕Current mucositis greater than Grade 1
- ✕Uncontrolled active infection
- ✕Prior cerebrovascular accident or hemorrhage
- ✕Congestive heart failure NYHA class III or IV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2a, Multi-center, Placebo-controlled, Randomized, Partially Blinded, Study Infused TK112690 or or Placebo Administered Along With Methotrexate Weekly for Four Consecutive Weeks to Patients With Recurrent or Residual SCCHN
In Brief
A Phase 2 clinical trial evaluating TK-112690 and Placebo TK-112690 for Mucositis. Completed, enrolled 22 participants across 3 sites.
Detailed Summary
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
Study Details
Timeline
Interventions
TK112690 treatment pre-methotrexate treatment
Placebo