Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to
paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.
Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin
or placebo until disease progression or unacceptable toxicity. The primary end-point is
disease control (complete response, partial response or stable disease, according to RECIST
1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular
markers in samples collected before and under treatment will be tested for correlation with
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Disease control at week 12
Number of subjects at week 12 with complete response, partial response or stable disease, over the total number of subjects, for each arm. Disease control means complete response, partial response or stable disease, according to RECIST 1.1.
Lucas V dos Santos, MD
Brazil: National Committee of Ethics in Research