Clinical Trial: Ixazomib Rollover Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies

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

Detailed Summary:

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.

Current Primary Outcome:

• Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an Adverse Event [AE] in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. This refers to an AE that may not result in death, be immediately life threatening, or require hospitalization, but may be considered serious when, based on appropriate medical judgment, may jeopardize the participant, require medical or surgical intervention to prevent 1 of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
• Number of Participants With ≥ Grade 3 AEs [ Time Frame: Up to 5 years ]
  An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
• Number of Participants With ≥ Grade 2 Peripheral Neuropathy [ Time Frame: Up to 5 years ]
• Number of Participants With New Primary Malignan
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Takeda
  

  Dates:
  Date Received: October 4, 2016
  Date Started: December 1, 2016
  Date Completion: October 1, 2021
  Last Updated: April 4, 2017
  Last Verified: April 2017