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NCT02412722 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT02412722 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 61 participants.
The verdict
NCT02412722, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purposes of this study are to evaluate the safety and tolerability of sapanisertib (MLN0128) milled active pharmaceutical ingredient (API) capsules administered both as a single agent and in combination with paclitaxel, to characterize the effect of a high-fat meal on the pharmacokinetics (PK) of sapanisertib milled API capsules, and to characterize the PK of sapanisertib milled API capsules when administered on an empty stomach approximately 24 hours after paclitaxel infusion.
Interventions
- DRUG Paclitaxel
- DRUG Sapanisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-03-26 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02412722
The ClinicalTrials.gov registry entry for NCT02412722 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 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 Paclitaxel is the first listed.
NCT02412722 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02412722 about?
NCT02412722 is a clinical study titled "A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies". The purposes of this study are to evaluate the safety and tolerability of sapanisertib (MLN0128) milled active pharmaceutical ingredient (API) capsules administered both as a single agent and in combination with paclitaxel, to characterize the effect of a high-fat meal on the pharmacokinetics (PK) o...
What is the current status of trial NCT02412722?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2015-03-26. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT02412722?
The interventions under investigation include: Paclitaxel (DRUG), Sapanisertib (DRUG).
Who is sponsoring clinical trial NCT02412722?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
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