drugset / Trial / NCT01677559

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

NCT01677559

Phase 1 Completed 34 enrolled Washington University School of Medicine
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-05-07
Primary completion
2014-09-30
Completion
2017-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisertib Small molecule 20 mg
Subject Alisertib Small molecule 30 mg
Subject Alisertib Small molecule 40 mg
Subject Alisertib Small molecule 50 mg
Background Paclitaxel Small molecule 100 mg/m2 Intravenous