Ixazomib Rollover Study



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:December 1, 2016
End Date:October 1, 2021

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

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

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.

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.
We found this trial at
5
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Hazard, Kentucky 41701
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Hazard, KY
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Leuven, 3001
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Leuven,
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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