Assessment of Safety and Therapeutic Efficacy of Promitil in Combination With Folfox in Patients With GI Malignancies
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
This single center, Phase 1b, prospective, dose limiting toxicity (DLT)-clearing study, will
assess the safety and efficacy of intravenously administered PROMITIL in combination with
FOLFOX in cancer patients with inoperable, locally advanced or metastatic GI solid tumors.
Based on previous clinical results, we hypothesized that the addition of PROMITIL to FOLFOX,
a treatment protocol consisting of oxaliplatin and fluoropyrimidine and commonly used to
treat gastrointestinal (GI) malignancies, may enhance the overall efficacy of this
combination regimen while maintain a reasonable safety profile.