CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 225 enrolled
Drug / intervention
Abemaciclib +1 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/NCT01394016
NCT01394016Phase 1Completed

A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer

Eli Lilly and Company·interventional·Posted Jul 14, 2011·Updated Sep 19, 2024

In Brief

A Phase 1 clinical trial evaluating Abemaciclib and Fulvestrant for Advanced Cancer. Completed, enrolled 225 participants across 3 sites.

Detailed Summary

The purpose of this study is to determine a safe dose of Abemaciclib to be given to participants with advanced cancer and to determine any side effects that may be associated with Abemaciclib in this population. Efficacy measures will be used to assess the activity of Abemaciclib in this population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2011
Enrollment StartDec 7, 2009
Primary CompletionMay 29, 2014
Study CompletionApr 12, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 15.0 years ago

Interventions

Abemaciclibdrug

Administered orally.

Fulvestrantdrug

Fulvestrant is administered intramuscularly into the buttocks in Part G only.