Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02924272
Registration number
NCT02924272
Ethics application status
Date submitted
4/10/2016
Date registered
5/10/2016
Date last updated
31/01/2023
Titles & IDs
Public title
Ixazomib Rollover Study
Query!
Scientific title
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies
Query!
Secondary ID [1]
0
0
U1111-1184-2041
Query!
Secondary ID [2]
0
0
C16027
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Lymphoma
0
0
Query!
Amyloidosis
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Metabolic disorders
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Other metabolic disorders
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ixazomib
Experimental: Ixazomib - 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.
Treatment: Drugs: Ixazomib
Ixazomib Capsules
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Serious Adverse Events (SAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to 5 years
Query!
Primary outcome [2]
0
0
Number of Participants With = Grade 3 AEs
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to 5 years
Query!
Primary outcome [3]
0
0
Number of Participants With = Grade 2 Peripheral Neuropathy
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to 5 years
Query!
Primary outcome [4]
0
0
Number of Participants With New Primary Malignancies
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to 5 years
Query!
Primary outcome [5]
0
0
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to 5 years
Query!
Primary outcome [6]
0
0
Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Up to 5 years
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/12/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2023
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
31
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Kentucky
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Massachusetts
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Missouri
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Leuven
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
China
Query!
State/province [7]
0
0
Beijing
Query!
Country [8]
0
0
China
Query!
State/province [8]
0
0
Hangzhou
Query!
Country [9]
0
0
China
Query!
State/province [9]
0
0
Shanghai
Query!
Country [10]
0
0
Greece
Query!
State/province [10]
0
0
Attiki
Query!
Country [11]
0
0
Greece
Query!
State/province [11]
0
0
Athens
Query!
Country [12]
0
0
Japan
Query!
State/province [12]
0
0
Tokyo
Query!
Country [13]
0
0
Korea, Republic of
Query!
State/province [13]
0
0
Seoul
Query!
Country [14]
0
0
Poland
Query!
State/province [14]
0
0
Slaskie
Query!
Country [15]
0
0
Poland
Query!
State/province [15]
0
0
Lodz
Query!
Country [16]
0
0
Poland
Query!
State/province [16]
0
0
Lublin
Query!
Country [17]
0
0
Poland
Query!
State/province [17]
0
0
Warszawa
Query!
Country [18]
0
0
Singapore
Query!
State/province [18]
0
0
Singapore
Query!
Country [19]
0
0
Spain
Query!
State/province [19]
0
0
Salamanca
Query!
Country [20]
0
0
Spain
Query!
State/province [20]
0
0
San Sebastian
Query!
Country [21]
0
0
Sweden
Query!
State/province [21]
0
0
Sodermanlands Lan
Query!
Country [22]
0
0
Sweden
Query!
State/province [22]
0
0
Lund
Query!
Country [23]
0
0
Sweden
Query!
State/province [23]
0
0
Stockholm
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Takeda
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Takeda Development Center Americas, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02924272
Query!
Trial related presentations / publications
Query!
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
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
Takeda
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02924272
Download to PDF