NCT01677559

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

Phase I Study Combining MLN8237 With Nab-Paclitaxel in Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma
• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	MLN8237
DRUG	nab-Paclitaxel

Timeline

• Start date: 2013-05-07
• Primary completion: 2014-09-30
• Completion: 2017-08-11
• First posted: 2012-09-03
• Last updated: 2018-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study