CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
LY900009 - Dose Escalation Phase (Part A) +1 moredrug
Likely dose
LY900009 - Dose Escalation Phase (Part A) 2 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/NCT01158404
NCT01158404Phase 1Completed
CompareCT.gov

Phase 1 Study of a Notch Inhibitor in Patients With Advanced Cancer

Eli Lilly and Company·interventional·Posted Jul 8, 2010·Updated Aug 9, 2019

In Brief

A Phase 1 clinical trial evaluating LY900009 - Dose Escalation Phase (Part A) and LY900009 - Dose Confirmation Phase (Part B) for Advanced Cancer. Completed, enrolled 35 participants across 2 sites.

Detailed Summary

The objective of this phase 1 study is to evaluate the safety and tolerability of Notch Inhibitor in participants with advanced cancer. This study includes dose escalation and dose confirmation components.

Study Details

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

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.0 years ago

Interventions

LY900009 - Dose Escalation Phase (Part A)drug

2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.

LY900009 - Dose Confirmation Phase (Part B)drug

30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle. Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met.