Ixazomib Rollover Study
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|ClinicalTrials.gov Identifier: NCT02924272|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : January 31, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Lymphoma Amyloidosis||Drug: Ixazomib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies|
|Actual Study Start Date :||December 16, 2016|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until 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 the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.
- 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 Malignancies [ Time Frame: Up to 5 years ]
- Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug [ Time Frame: Up to 5 years ]
- Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event [ Time Frame: Up to 5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 treatment in the parent study or as agreed by the Takeda clinician/designee.
Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Participants will be eligible to enter the rollover study when:
- The parent study is closed or planned to be closed; and
- The participant is on ixazomib monotherapy, a combination regimen with ixazomib and other study medication(s), on a placebo combination, or on an alternative arm regimen in a designated ixazomib parent study (i.e., Studies C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685], C16007 [NCT01318902], C16008 [NCT01383928], C16010 Global [NCT01564537], C16011 [NCT01659658], C16013 [NCT01645930], C16014 Global [NCT01850524] and Korean Continuation, C16017 [NCT01939899], C16020 [NCT02046070], C16029 [NCT03170882], and C16047 [NCT03439293]); and
- In the opinion of the investigator and approved by the Takeda medical monitor, the participant may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (e.g., response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (e.g., commercial supply).
- Agree to continue to practice contraceptive methods as outlined in the parent study.
- The participant meets any of the criteria for treatment discontinuation in the parent study.
- Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924272
|Study Director:||Study Director||Takeda|
|Other Study ID Numbers:||
U1111-1184-2041 ( Other Identifier: WHO )
2016-001681-28 ( EudraCT Number )
|First Posted:||October 5, 2016 Key Record Dates|
|Last Update Posted:||January 31, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Access Criteria:||IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action