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NCT01045421 · ClinicalTrials.gov registry record · Phase 1
Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 273
- Enrollment target
NCT01045421: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT01045421 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 273 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (355% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01045421, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 273 participants
- Enrollment target
Study Summary
This is an open-label, multicenter study with a phase 1 dose escalation portion and a 2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced nonhematological malignancies.
Primary Outcome
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count \<500 cells/cubic meter \[cells/mm\^3\]) for \>7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets \<25,000 cells/mm3) for \>7 days; Platelet count \<10,000 cells/mm3; Grade 3 thrombocytopenia with clinically sig
Interventions
- DRUG MLN8237 (Alisertib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01045421 record still lists
NCT01045421 is an interventional study that assigns participants to a tested intervention. The registered 273 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 (355% higher).
The record links to 0 conditions, and to 1 intervention - of which MLN8237 (Alisertib) is the first listed.
NCT01045421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01045421 about?
NCT01045421 is a clinical study titled "Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies". This is an open-label, multicenter study with a phase 1 dose escalation portion and a 2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced nonhematological malignancies.
What is the current status of trial NCT01045421?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 273 participants. The study started on 2010-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01045421?
The interventions under investigation include: MLN8237 (Alisertib) (DRUG).
Who is sponsoring clinical trial NCT01045421?
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 NCT01045421's enrollment target sits among peer trials
273 149th of 2000 higher than 1,852 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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