At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
dalotuzumab (MK0646)drug
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.
A Study to Establish Proof-of-Biology for MK-0646 in Breast Cancer
In Brief
A Phase 1 clinical trial evaluating dalotuzumab (MK0646) for Breast Cancer. Completed, enrolled 48 participants.
Detailed Summary
A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartSep 2008
Primary CompletionFeb 2010
TodayJul 2026
First PostedSep 25, 2008
Enrollment StartSep 30, 2008
Primary CompletionFeb 17, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.8 years ago
Interventions
dalotuzumab (MK0646)drug
Single intravenous infusion