drugset
drugset / Trial / NCT03000374

Induction Therapy With Panitumumab + mFOLFOX-6 in Rectal Cancer and Quadruple Wild-type Mutation Before Surgery

NCT03000374 ↗

Phase 2 Completed 34 enrolled Grupo Espanol Multidisciplinario del Cancer Digestivo Amgen · collabPivotal S.L. · collab
NaSingle-groupOpen-labelTreatment

Summary

Patients with rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging \[MRI\]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment, will receive a preoperative Induction therapy with 12 weeks of panitumumab with mFOLFOX-6 to evaluate the efficacy in terms of pathologic complete response (pCR)

Timeline

Start
2017-05-30
Primary completion
2020-10-31
Completion
2021-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Background Leucovorin Small molecule 200 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

rectal cancer