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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
Scientific title
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies
Secondary ID [1] 0 0
U1111-1184-2041
Secondary ID [2] 0 0
C16027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Lymphoma 0 0
Amyloidosis 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 5 years
Primary outcome [2] 0 0
Number of Participants With = Grade 3 AEs
Timepoint [2] 0 0
Up to 5 years
Primary outcome [3] 0 0
Number of Participants With = Grade 2 Peripheral Neuropathy
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
Number of Participants With New Primary Malignancies
Timepoint [4] 0 0
Up to 5 years
Primary outcome [5] 0 0
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug
Timepoint [5] 0 0
Up to 5 years
Primary outcome [6] 0 0
Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event
Timepoint [6] 0 0
Up to 5 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Hangzhou
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
Greece
State/province [10] 0 0
Attiki
Country [11] 0 0
Greece
State/province [11] 0 0
Athens
Country [12] 0 0
Japan
State/province [12] 0 0
Tokyo
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Poland
State/province [14] 0 0
Slaskie
Country [15] 0 0
Poland
State/province [15] 0 0
Lodz
Country [16] 0 0
Poland
State/province [16] 0 0
Lublin
Country [17] 0 0
Poland
State/province [17] 0 0
Warszawa
Country [18] 0 0
Singapore
State/province [18] 0 0
Singapore
Country [19] 0 0
Spain
State/province [19] 0 0
Salamanca
Country [20] 0 0
Spain
State/province [20] 0 0
San Sebastian
Country [21] 0 0
Sweden
State/province [21] 0 0
Sodermanlands Lan
Country [22] 0 0
Sweden
State/province [22] 0 0
Lund
Country [23] 0 0
Sweden
State/province [23] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Takeda Development Center Americas, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02924272
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries