At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 101 enrolled
Drug / intervention
TAK-228 +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.
A Multicenter, Open-label, Phase 1b Study of MLN0128 (an Oral mTORC1/2 Inhibitor) in Combination With MLN1117 (an Oral PI3Kα Inhibitor) in Adult Patients With Advanced Nonhematologic Malignancies
In Brief
A Phase 1 clinical trial evaluating TAK-228 and TAK-117 for Advanced Nonhematologic Malignancies. Completed, enrolled 101 participants across 5 sites in 3 countries.
Detailed Summary
The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117. It also evaluated the single- and multiple-dose plasma pharmacokinetics (PK) of TAK-228+TAK-117 in participants with advanced nonhematologic malignancies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Nonhematologic Malignancies
CountriesSpain, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJul 2013
Primary CompletionJan 2017
Study CompletionApr 2018
TodayJul 2026
First PostedJul 15, 2013
Enrollment StartJun 28, 2013
Primary CompletionJan 31, 2017
Study CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.0 years ago
Interventions
TAK-228drug
TAK-228 Capsules
TAK-117drug
TAK-117 Capsules