Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer

Study acronym: NOTABLE-308
StatusWithdrawn
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Withdrawn before enrolling Sponsor's reason: Study withdrawn before enrollment of any participant due to a corporate strategic decision. Not related to safety or efficacy concerns. Show 6 more changesShow less
    • Enrollment target: estimated 420 to confirmed 0
    • Start date: Apr 2024 to Apr 3, 2024
    • Interventions: Nimotuzumab injection (Drug), Placebo (Drug), Trifluridine/tipiracil (Drug) to Nimotuzumab injection (Drug), Placebo (Drug), Trifluridine/tipiracil (Drug)
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Study description revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS).
Trial Details
NCT Number NCT06343116
Lead Sponsor Biotech Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Refractory Metastatic Colorectal Cancer
Related terms Colorectal Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov