Advanced Malignancies Clinical Trial
Official title:
An Open-Label, Dose Escalation Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors
To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14-day recovery period.
The drug tested in this study is called alisertib. Alisertib is being tested to treat people
who have advanced malignancies. This study determined the dose-limiting toxicity, maximum
tolerated dose, safety and pharmacokinetics (how the drug moves through the body) for
alisertib when given once or twice a day for 7 to 21 days. This open label study enrolled 87
participants. Participants were enrolled in one of 3 treatment groups:
- Powder-in-Capsule (PIC) Dose Escalation (alisertib 5, 10, 20, 40, 80, 110 or 150 mg PIC
, once daily (QD) for 7 days (D),or alisertib 25 mg, PIC, orally, QD 14D, or alisertib
25, 50 or 70 mg, PIC, orally, QD 21D, or alisertib 50 or 60 mg, PIC, orally, twice daily
(BID) 7D, alisertib 40 mg, PIC, orally, BID 14D
- ECT Dose Escalation (alisertib 10 or 20 mg, Enteric-coated Tablets (ECT), orally, QD for
7 to 21 days
- Relative Bioavailability (alisertib 40 mg ECT or PIC, orally, BID 7D in cycle 1,
followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, BID 7D in
cycle 2, followed by alisertib 50 mg PIC orally, BID 7D in each additional All
participants received treatment until their disease progressed or they experienced
unacceptable alisertib-related toxicity. This multi-center trial was conducted in the
United States. The overall time to participate in this study was 1011 days. Participants
made multiple visits to the clinic, including a final visit 30 days after receiving
their last dose of alisertib for a follow-up assessment.
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