NCT02924272

Ixazomib Rollover Study

An Open-Label, Rollover Protocol for Patients Previously Enrolled in Takeda-Sponsored Ixazomib Studies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.

Detailed 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 Takeda-sponsored clinical study, and in the investigator's opinion and approved by the Takeda medical monitor, may benefit from continued ixazomib therapy. The study will enroll approximately 250 patients. All participants will receive ixazomib as a single agent or in combination with other study drugs 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 is transitioned to ixazomib/other therapy 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 study drug for a safety assessment.

Conditions

• Multiple Myeloma
• Lymphoma
• Amyloidosis

Interventions

Type	Name	Description
DRUG	Ixazomib	Ixazomib Capsules

Timeline

• Start date: 2016-12-16
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2016-10-05
• Last updated: 2025-03-12
• Results posted: 2025-03-12

Locations

26 sites across 11 countries: United States, Belgium, Canada, China, Greece, Japan, Poland, Singapore, South Korea, Spain, Sweden

Regulatory

• FDA-regulated drug study