CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
LY2523355 +1 moredrug
Likely dose
LY2523355 5 milligramsfrom 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/NCT01059643
NCT01059643Phase 2Completed
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A Phase 2 Indication Identification Study of LY2523355 in Patients With Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck

Eli Lilly and Company·interventional·Posted Feb 1, 2010·Updated Sep 18, 2019

In Brief

A Phase 2 clinical trial evaluating LY2523355 and pegfilgrastim for Ovarian Cancer and 6 related conditions. Completed, enrolled 103 participants across 18 sites.

Detailed Summary

The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Non Small Cell Lung Cancer, Prostate Cancer, Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cancer of Head and Neck
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2010
Enrollment StartApr 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.4 years ago

Interventions

LY2523355drug

Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a 1-hour infusion on Days 1, 2 and 3 of a 21 day cycle; for up to 2 cycles (4 cycles for prostate cancer patients). Additional cycles administered based on patient response assessment.

pegfilgrastimdrug

6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer patients). Additional cycles of LY2523355 administered based on patient response assessment.