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NCT01094288 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

A Phase 1 study, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT01094288: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.

NCT01094288 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01094288, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and tolerability of alisertib in combination with docetaxel as a treatment for participants with advanced solid tumors, including castration-resistant prostate cancer, who were deemed by the investigator to be medically appropriate candidates for docetaxel therapy.

Primary Outcome

An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in

Interventions

  • DRUG Docetaxel
  • DRUG Alisertib

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2010-08-17
Est. Completion 2017-01-04
Phase Phase 1
Millennium Pharmaceuticals

135 total trials

What the finished NCT01094288 record still lists

NCT01094288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.

NCT01094288 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01094288 about?

NCT01094288 is a clinical study titled "A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen". The purpose of this study is to evaluate the safety and tolerability of alisertib in combination with docetaxel as a treatment for participants with advanced solid tumors, including castration-resistant prostate cancer, who were deemed by the investigator to be medically appropriate candidates for d...

What is the current status of trial NCT01094288?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2010-08-17. Estimated completion is 2017-01-04.

What interventions are being tested in trial NCT01094288?

The interventions under investigation include: Docetaxel (DRUG), Alisertib (DRUG).

Who is sponsoring clinical trial NCT01094288?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01094288's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 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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Source: ClinicalTrials.gov NCT01094288, the US trial registry maintained by the National Library of Medicine. NCT01094288 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.