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NCT01351350 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT01351350: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT01351350 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01351350, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.
Primary Outcome
MTD is the highest dose level at which the participants tolerate treatment without dose-limiting toxicities during the first cycle (28 days) of therapy.
Interventions
- DRUG trastuzumab
- DRUG paclitaxel
- DRUG MLN0128
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-02-28 |
| Est. Completion | 2017-09-15 |
| Phase | Phase 1 |
What the finished NCT01351350 record still lists
NCT01351350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which trastuzumab is the first listed.
NCT01351350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01351350 about?
NCT01351350 is a clinical study titled "Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies". This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.
What is the current status of trial NCT01351350?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2011-02-28. Estimated completion is 2017-09-15.
What interventions are being tested in trial NCT01351350?
The interventions under investigation include: trastuzumab (DRUG), paclitaxel (DRUG), MLN0128 (DRUG).
Who is sponsoring clinical trial NCT01351350?
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 NCT01351350's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 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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