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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02924272
Registration number
NCT02924272
Ethics application status
Date submitted
4/10/2016
Date registered
5/10/2016
Date last updated
12/03/2025
Titles & IDs
Public title
Ixazomib Rollover Study
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Scientific title
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Takeda-Sponsored Ixazomib Studies
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Secondary ID [1]
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U1111-1184-2041
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Secondary ID [2]
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C16027
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Lymphoma
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Amyloidosis
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Condition category
Condition code
Metabolic and Endocrine
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Metabolic disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ixazomib
Experimental: Ixazomib Monotherapy - Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
Experimental: Ixazomib Combination Therapy - Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
Treatment: Drugs: Ixazomib
Ixazomib Capsules
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an 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.
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Timepoint [1]
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Up to 7 years
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Primary outcome [2]
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Number of Participants With = Grade 3 AEs
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Assessment method [2]
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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 (e.g., 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. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE.
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Timepoint [2]
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Up to 7 years
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Primary outcome [3]
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Number of Participants With = Grade 2 Peripheral Neuropathy
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Assessment method [3]
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Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated.
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Timepoint [3]
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Up to 7 years
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Primary outcome [4]
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Number of Participants With New Primary Malignancies
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Assessment method [4]
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Timepoint [4]
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Up to 7 years
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Primary outcome [5]
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Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug
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Assessment method [5]
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An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product.
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Timepoint [5]
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Up to 7 years
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Primary outcome [6]
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Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event
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Assessment method [6]
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An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Any AE interpreted by the investigator as a clinically significant event was reported.
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Timepoint [6]
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Up to 7 years
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Eligibility
Key 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 treatment in the parent study or as agreed by the Takeda clinician/designee.
2. 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:
1. The parent study is closed or planned to be closed; and
2. 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
3. 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).
3. Agree to continue to practice contraceptive methods as outlined in the parent study.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. The participant meets any of the criteria for treatment discontinuation in the parent study.
2. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/12/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/07/2024
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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State/province [1]
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Georgia
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United States of America
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State/province [2]
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Missouri
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Belgium
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Leuven
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Canada
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Ontario
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China
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State/province [7]
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Beijing
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Country [8]
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China
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Hangzhou
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China
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Shanghai
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Greece
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Attiki
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Greece
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Athens
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Japan
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Tokyo
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Korea, Republic of
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State/province [13]
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Seoul
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Country [14]
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Poland
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State/province [14]
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Slaskie
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Poland
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Lodz
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Poland
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Lublin
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Poland
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State/province [17]
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Warszawa
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Singapore
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Singapore
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Spain
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Salamanca
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Spain
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San Sebastian
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Sweden
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Sodermanlands Lan
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Sweden
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Lund
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Sweden
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Takeda Development Center Americas, Inc.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.
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Trial website
https://clinicaltrials.gov/study/NCT02924272
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/72/NCT02924272/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/72/NCT02924272/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02924272
Download to PDF