Ovarian Cancer Clinical Trial
Official title:
A Phase 1b Study of Alisertib (MLN8237) in Combination With Weekly Paclitaxel in East Asian Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability and determine the MTD to subsequently define an RP2D of alisertib in combination with weekly paclitaxel in East Asian participants with advanced solid tumors.
The drug being tested in this study was called alisertib. Alisertib in combination with
paclitaxel was tested to find a safe and well-tolerated dose in East Asian participants. The
study consisted of 2 parts: a dose escalation phase to determine the maximum tolerated dose
(MTD) and define the recommended phase 2 dose (RP2D) of the alisertib plus paclitaxel
combination in East Asian participants with advanced solid tumors; the second part is an
expansion cohort at the RP2D of the alisertib plus paclitaxel in East Asian participants with
either ovarian cancer or small cell lung cancer. This study looked at safety (lab results and
side effects) and pharmacokinetic properties (how the drugs move throughout the body).
This open label study enrolled 9 participants. Dose Escalation Phase: Alisertib tablets at a
starting dose of 15 mg, orally, twice daily, 3 days on/4 days off for 3 weeks in 28 day cycle
in combination with paclitaxel, 60 mg/m^2 intravenous on days 1, 8, and 15 in 28-day cycles
in Cohort 1 escalated to a dose of 25 mg alisertib, orally, twice daily 3 days on/4 days off
for 3 weeks in 28 day cycles in Cohort 2. If ≥ 2 participants experience a dose limiting
toxicity (DLT) the dose of alisertib decreased to 20 mg. Expansion Cohort: alisertib tablets
at the determined RP2D dose orally, twice daily 3 days on/4 days off for 3 weeks in 28 day
cycles in combination with paclitaxel, 60 mg/m^2 intravenous. Treatment was continued until
disease progression or unacceptable toxicity.
- Alisertib 15 mg to 25 mg tablets
- Paclitaxel 60 mg/m^2 intravenous solution
This multi-centre trial was conducted in Japan and Korea. The overall time to participate in
this study was up to 24 months.
The study was terminated early because of the sponsor's decision. Enrollment was completed in
the dose escalation cohort, but no participants were enrolled in the dose expansion cohort.
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