drugset / Trial / NCT01677559
Combining MLN8237 With Nab-Paclitaxel in Patients With Advanced Solid Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |