Advanced Solid Tumors Clinical Trial
Official title:
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
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.
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.
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