BENITIONSClinical Trial Intelligence

A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

Phase 2 Active, not recruiting NCT02711553

ConditionBiliary Tract Cancer, Metastatic Cancer, Advanced Cancer
PhasePhase 2
SponsorEli Lilly and Company
StatusActive, not recruiting
Enrollment309 participants
InterventionsRamucirumab, Merestinib, Cisplatin, Gemcitabine, Placebo Oral
Start dateMay 19, 2016
Completion dateFeb 16, 2018
Results postedFeb 26, 2021

Summary

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

Progression Free Survival (PFS)

Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months) · Months

8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine6.47 Months
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine6.97 Months
Pooled Placebo6.64 Months
p-value0.4821
Hazard Ratio (HR)1.123 (95% CI 0.904–1.395)

Open in BENITIONS View on ClinicalTrials.gov

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