CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
LY2495655 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01505530
NCT01505530Phase 2Completed

A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients With Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

Eli Lilly and Company·interventional·Posted Jan 6, 2012·Updated Sep 18, 2019

In Brief

A Phase 2 clinical trial evaluating LY2495655, Placebo, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 125 participants across 21 sites in 5 countries.

Detailed Summary

This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Israel, Norway, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2012
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2014
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.5 years ago

Interventions

LY2495655drug

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

Placebodrug

Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

Standard of Care Chemotherapydrug

Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).