Multiple Myeloma Clinical Trial
Official title:
An Open-label, Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Hematological Malignancies
This is an open-label, multicenter, phase 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.
The drug being tested in this study is called alisertib. Alisertib is being tested to treat
people who have advanced hematological 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 58 patients. Participants were enrolled in one of 3 treatment
groups:
- Part 1: Powder-in-Capsule (PIC) Dose Escalation (alisertib 25 mg PIC, orally twice daily
[BID] on Day 1 [loading dose] and then alisertib 25 or 35 mg PIC once daily [QD] for 21
days (D), or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14D) in 28-day cycles
- Part 1: Enteric-coated Tablet (ECT) Dose Escalation (alisertib 40 mg, ECT, orally, QD
for 14D or alisertib 30, 40 or 50 mg, orally, BID for 7D) in 28-day cycles
- Part 2: Participants with Peripheral T-cell Lymphoma (PTCL) (alisertib 50 mg ECT,
orally, BID for 7D) in 21-day cycles
All participants received treatment for 12 months or 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 422 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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