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NCT01677559 · ClinicalTrials.gov registry record · Phase 1

Combining MLN8237 With Nab-Paclitaxel in Patients With Advanced Solid Malignancies

A Phase 1 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT01677559: Completed Phase 1 study, sponsored by Washington University School of Medicine.

NCT01677559 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01677559, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and the best dose of MLN8237 (alisertib) when given together with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with solid malignancies that are metastatic or cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as nab-paclitaxel work by killing the cells or by stopping them from dividing. Giving alisertib together with nab-paclitaxel may provide a more effective anticancer treatment with fewer side effects.

Interventions

  • DRUG nab-Paclitaxel
  • DRUG MLN8237

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2013-05-07
Est. Completion 2017-08-11
Phase Phase 1

What the finished NCT01677559 record still lists

NCT01677559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

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

NCT01677559 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01677559 about?

NCT01677559 is a clinical study titled "Combining MLN8237 With Nab-Paclitaxel in Patients With Advanced Solid Malignancies". This phase I trial studies the side effects and the best dose of MLN8237 (alisertib) when given together with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with solid malignancies that are metastatic or cannot be removed by surgery. Alisertib may stop t...

What is the current status of trial NCT01677559?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2013-05-07. Estimated completion is 2017-08-11.

What interventions are being tested in trial NCT01677559?

The interventions under investigation include: nab-Paclitaxel (DRUG), MLN8237 (DRUG).

Who is sponsoring clinical trial NCT01677559?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01677559's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 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 NCT01677559, the US trial registry maintained by the National Library of Medicine. NCT01677559 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.