NCT01091428

Alisertib (MLN8237) in Participants With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer

Randomized Phase 2 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase 1 Portion in Patients With Ovarian or Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter study with a nonrandomized Phase 1 portion and an open-label, randomized, Phase 2 portion evaluating MLN8237 in combination with weekly paclitaxel in adult female participants with advanced breast cancer (Phase 1 portion only) and recurrent ovarian cancer (both Phase 1 and Phase 2 portions).

Detailed description

The drug tested in this study was called alisertib. Alisertib was tested to treat people who have ovarian and breast cancer. This study looked at safety, any anti-tumor effect, and it also determined a recommended dose of alisertib plus paclitaxel to take into further studies. Pharmacokinetic blood samples were studied to characterize any effects on the concentration of each of the drugs when administered together. The study enrolled 191 patients. Participants with Breast Cancer and Ovarian Cancer received one of the following escalating doses of alisertib in combination with paclitaxel in the Phase 1 lead-in portion of the study: * Alisertib 10 mg BID + Paclitaxel 80 mg/m\^2 * Alisertib 20 mg BID + Paclitaxel 80 mg/m\^2 * Alisertib 20 mg BID + Paclitaxel 60 mg/m\^2 * Alisertib 30 mg BID + Paclitaxel 60 mg/m\^2 * Alisertib 40 mg BID + Paclitaxel 60 mg/m\^2 * Alisertib 50 mg BID + Paclitaxel 60 mg/m\^2 Once the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) was determined, participants were randomized to receive the following treatments in the Phase 2 portion of the study: * Alisertib 40 mg BID + Paclitaxel 60 mg/m\^2 * Paclitaxel 80 mg/m\^2 This multi-center trial was conducted in the United States, Poland and France. The overall time to participate in this study was approximately 5 years. Participants made multiple visits to the clinic, and who did not experience disease progression (PD) were followed off-treatment once every 8 weeks until the occurrence of 110 progression-free survival (PFS) events.

Conditions

• Ovarian Carcinoma
• Fallopian Tube Cancer
• Peritoneal Cancer
• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Alisertib	Alisertib tablets
DRUG	Paclitaxel	Paclitaxel intravenous infusion

Timeline

• Start date: 2010-04-16
• Primary completion: 2014-08-12
• Completion: 2017-07-19
• First posted: 2010-03-24
• Last updated: 2018-06-04
• Results posted: 2018-06-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study