At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 125 enrolled
Drug / intervention
TAK-117drug
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 Phase I, Dose Escalation Study of MLN1117 in Subjects With Advanced Solid Malignancies Followed by Expansion in Subjects With Measurable Disease
In Brief
A Phase 1 clinical trial evaluating TAK-117 for Metastatic Solid Tumors. Completed, enrolled 125 participants across 5 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced solid malignancies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Solid Tumors
CountriesSpain, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionJul 2015
Study CompletionJan 2016
TodayJul 2026
First PostedOct 10, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.7 years ago
Interventions
TAK-117drug
oral administration of TAK-117, daily and intermittent schedules.