Ixazomib Rollover Study

• Status: Active, not recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Glycine; Ixazomib

Criteria

Inclusion Criteria:

1. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of ixazomib in the parent study or as agreed by the Millennium clinician/designee.

2. Previously treated with ixazomib (excluding comparator or placebo participants not on current treatment with ixazomib) in a Millennium sponsored study. Participants will be eligible to enter the rollover study when:

1. The parent study is closed or planned to be closed; and

2. The participant is on ixazomib monotherapy or on a drug combination with another medication, established while in his/her parent study; and

3. In the opinion of the investigator and confirmed by the Millennium medical monitor, the participant may continue to benefit from treatment with ixazomib (eg, response to therapy or stable disease without evidence of disease progression).

Exclusion Criteria:

1. The participant meets any of the criteria for treatment discontinuation in the parent study.