NCT01094288

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 of MLN8237, an Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have advanced solid tumors including castration-resistant prostate cancer. The study enrolled approximately 41 patients. Participants were enrolled to receive: • Alisertib 10-40 mg + docetaxel 60-75 mg/m\^2 All participants will receive alisertib (ECT) in dose escalating cohorts, orally, twice daily for 7 days followed by 14-day rest period in Cycle 1, 3 and onwards (21-day cycle) and orally twice daily from Day 3 to Day 7 followed by 14 day rest period in Cycle 2 \[dose held for pharmacokinetic (PK) collection\] along with docetaxel 75 mg/m\^2, intravenous (IV) infusion on Day 1 of each cycle for maximum of 12 months, or until the occurrence of progressive disease (PD), unmanageable AEs or withdrawal of consent. This multi-center trial is conducted in United States. The overall time to participate in this study was until there is evidence of disease progression or unacceptable treatment-related toxicity. Participants made multiple visits to the clinic, and were contacted every 12 weeks for up to 25.8 months after last dose of study drug for a follow-up assessment.

Conditions

• Advanced Solid Tumors
• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	Alisertib	Alisertib ECT
DRUG	Docetaxel	Docetaxel IV infusion

Timeline

• Start date: 2010-08-17
• Primary completion: 2014-02-28
• Completion: 2017-01-04
• First posted: 2010-03-26
• Last updated: 2019-02-15
• Results posted: 2019-02-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study