Last updated on February 2019

Ixazomib Rollover Study

Brief description of study

The purpose of this study is to provide continued access to ixazomib and evaluation of the long-term safety profile of ixazomib.

Detailed Study Description

The drug being tested in this study is called ixazomib. This study will look at the long term safety profile of ixazomib in participants who have previously received and tolerated ixazomib in a Millennium-sponsored clinical study, and in the investigator's opinion and confirmed by the Millennium medical monitor, may benefit from continued ixazomib therapy.

The study will enroll approximately 250 patients.

All participants will receive ixazomib at same dose and schedule that they were receiving in the parent study until they experience disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until ixazomib is available to the participant through commercial channels, including reimbursement for the participant's indication, whichever is sooner.

This multicenter, rollover study will be conducted worldwide. The overall time to participate in this study is up to 7 years. Participants will make multiple visits to the clinic, and a final visit after 30 days of last dose of ixazomib for a safety assessment.

Clinical Study Identifier: NCT02924272

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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