Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation and Pharmacokinetic Study of Alisertib (MLN8237), an Aurora A Kinase Inhibitor, in Adult East Asian Patients With Advanced Solid Tumors or Lymphomas
The purpose of this study was to determine the safety profile, maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to characterize the pharmacokinetic (PK) profile of alisertib twice daily (BID) dosing for 7 days in East Asian participants with advanced solid tumors or lymphomas. The secondary objective was to describe any antitumor activity that may have been observed with alisertib treatment.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested
to treat people who have advanced solid tumors or lymphomas for which standard curative or
life-prolonging treatment did not exist or was no longer effective or tolerable. This study
evaluated the safety and pharmacokinetic (PK) profile, and maximum tolerated dose (MTD) and
recommended Phase 2 dose (RP2D) of alisertib, as well as any antitumor activity.
The study enrolled 36 patients. Participants were assigned to one of the two treatment groups
and received:
- Alisertib 30 mg
- Alisertib 40 mg All participants took two enteric-coated tablets every 12 hours each day
for 7 days followed by a 14-day rest period in a 21-day cycle for up to 16 cycles.
This multi-center trial is conducted in East Asia. The overall time to participate in this
study was 24 months, unless it was determined that a participant would derive benefit from
continued therapy beyond 24 months. Participants made multiple visits to the clinic, and were
contacted up to a maximum of 30 days after last dose of study drug for a follow-up
assessment.
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|---|---|---|---|
| Active, not recruiting |
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