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NCT01899053 · ClinicalTrials.gov registry record · Phase 1
A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT01899053 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 101 participants.
The verdict
NCT01899053, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study 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.
Interventions
- DRUG TAK-228
- DRUG TAK-117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2013-06-28 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01899053
The ClinicalTrials.gov registry entry for NCT01899053 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TAK-228 is the first listed.
NCT01899053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01899053 about?
NCT01899053 is a clinical study titled "A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies". 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 TA...
What is the current status of trial NCT01899053?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2013-06-28. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT01899053?
The interventions under investigation include: TAK-228 (DRUG), TAK-117 (DRUG).
Who is sponsoring clinical trial NCT01899053?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
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