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NCT01449370 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
NCT01449370: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT01449370 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 125 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01449370, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
Study 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.
Primary Outcome
MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for \>14 days. Grade 3: nausea and/or vomiting/diarrhea for \>7 days; rash for \>7 days; thrombocytopenia with bleeding; fasting hyperglycemia for \>24 hours(hr). Grade \>=3:nonhematologic toxicity considered clinically signific
Interventions
- DRUG TAK-117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT01449370 record still lists
NCT01449370 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher).
The record links to 0 conditions, and to 1 intervention - of which TAK-117 is the first listed.
NCT01449370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01449370 about?
NCT01449370 is a clinical study titled "Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer". 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.
What is the current status of trial NCT01449370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2011-10. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01449370?
The interventions under investigation include: TAK-117 (DRUG).
Who is sponsoring clinical trial NCT01449370?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01449370's enrollment target sits among peer trials
125 467th of 2000 higher than 1,530 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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